Recurring concern

Inadequate product safety warnings about serious hazards

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First reported 16 Oct 2013•Latest report 4 Nov 2025

Definition

What this concern includes

Includes failures of product packaging, labels or enclosed product information to provide sufficiently visible, prominent, complete and intelligible warnings about serious hazards associated with using or misusing the product, including inhalation, poisoning, fire, choking and comparable risks.

Not included

  • Excludes road, premises, workplace and public-location warning signs where the warning is not part of product packaging or product information.
  • Excludes generic product defects or unsafe product design where the warning or labelling control is not itself deficient.
  • Excludes dosage, instructions or general consumer information unless the reported deficiency concerns communicating a serious product-safety hazard through packaging or accompanying product information.
  • Excludes warnings for a named clinical, transport or operational safety system where that system supplies the more specific supported parent boundary.
Reports
20

Distinct published reports

Individual concerns
26

A report can raise multiple concerns

Date range
2013–2025

First to latest report issue date

Stated actions
48

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care5
Medicines and Healthcare products Regulatory Agency5
NHS England4
Food Standards Agency3
Care Quality Commission2
Proprietary Association of Great Britain2
Alliance Pharmaceuticals Limited1
Arjo UK Limited1
Bayer plc1
Bradford District Care NHS Foundation Trust1
British Aerosol Manufacturers' Association1
Churchgate Surgery1
Decathlon UK1
Department for Business, Energy & Industrial Strategy1
Department for Business, Innovation, Science and Trade1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. Manchester South

    AI-generated summary

    Oliver Luke Gorman · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Oliver Luke Gorman, aged 12, died at home on 5 May 2025 after inhaling butane gas from an aerosol spray. The report raised concerns about the lack of age restrictions on some products containing butane or propane, the adequacy of warnings about inhalation risks, and social media content promoting dangerous challenges.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Inadequate visibility and wording of aerosol inhalation warnings

    Wider context from the report

    “2. Adequacy of Warning The warnings on the cans of ████████ of the danger/risk of inhaling the aerosol spray were, in my opinion, inadequate in terms of visibility and wording. The warning was set in an area outline of about 12mm x 12mm, in black or white writing depending on the background colour of the can. It was lost amongst all the other information and writing on the can. At least the ‘inflammable content’ warning was outlined in red. The warning stated “SOLVENT ABUSE CAN KILL INSTANTLY”. Many people (both adults and children) may not equate inhalation of aerosol spray with solvent abuse. Thus, the warning does not appear to properly describe the risks of using/misusing using the product. That risk being inhalation of this aerosol spray can cause instant death. ”

    Source location

    Oliver Luke Gorman · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Developed and updated guidance for a prominent inhalation caution mark, including revised wording, placement and visibility specifications.

    Verbatim wording from the response

    “Earlier this year, following work with Re-Solv, academia, and consumers on the changing use of language, BAMA updated its advice. It proposed an alternative mark that reads: “Intentional misuse can kill instantly. Do not deliberately inhale” along with suggested wording for an additional cautionary statement. There is also a recommendation regarding where this mark should be placed to make it more prominent to users. More details can be found below or on the BAMA website.”

    Source location

    Response from British Aerosol Manufacturers Association
    Page 2 · response
    Published 5 November 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Promote existing and updated caution labels and encourage aerosol marketers to adopt them across products placed on the UK market.

    Verbatim wording from the response

    “BAMA believes that providing information and education on ████████ safety is essential and is committed to ensuring that aerosol marketers provide prominent caution marks on pack, which we believe would be more effective than imposing age restrictions on the sale of ████████. Since the late 1990s, BAMA has asked those placing aerosols on the UK market to add a voluntary caution mark alongside the product information, in addition to the legally required text, that reads “Solvent Abuse Can Kill Instantly” (SACKI).”

    Source location

    Response from British Aerosol Manufacturers Association
    Page 1 · response
    Published 5 November 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Encourage aerosol manufacturers to adopt the updated inhalation-risk warning.

    Verbatim wording from the response

    “I understand that one of the UK market leaders in this industry will implement the new messaging from January 2026, meaning a significant proportion of aerosol products in the UK will soon carry the new label. While this will be voluntary, we expect other businesses to follow suit, and OPSS will be encouraging all aerosol manufacturers to take up the new warning. I understand the BAMA will also encourage their membership to make the change as soon as possible.”

    Source location

    Response from Product Safety & Standards
    Page 3 · response
    Published 5 November 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Monitor voluntary uptake of the updated warning and communicate expectations for industry adoption.

    Verbatim wording from the response

    “OPSS, with the BAMA’s support, will monitor the progress on the voluntary uptake of the new labelling and we will make clear that we expect industry to be following this updated best practice for products where it is most relevant.”

    Source location

    Response from Product Safety & Standards
    Page 3 · response
    Published 5 November 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Improved on-pack labelling and point-of-use information are considered sufficient, making retail age restrictions on aerosol sales unnecessary.

    Verbatim wording from the response

    “Like other household products, aerosols are safe when used according to the manufacturer's instructions. Products are tested to ensure they comply with all relevant regulations and are labelled, as a minimum, in accordance with those regulations. We believe that the labelling of products, as detailed above, is the best way to raise awareness of the potential dangers of misusing an aerosol, including for parents and those caring for young people.”

    Source location

    Response from British Aerosol Manufacturers Association
    Page 2 · response
    Published 5 November 2025

    Open published response
  2. Hampshire, Portsmouth and Southampton

    AI-generated summary

    Thomas Oliver HILL · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Thomas Oliver HILL died on 28 October 2015 after inhaling a fatal quantity of carbon monoxide from a flue-less liquefied petroleum gas cabinet heater while preparing for a bath. The report identified concerns about the heater being used in an undersized room, the absence of a visible external warning label, and it not being obvious to all users that adequate room dimensions were required for safe use.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Absence of a visible external warning label on flue-less liquified petroleum gas cabinet heaters

    Wider context from the report

    “The flue-less liquified petroleum gas cabinet heater was operated in a room which was too small dimension so to safely use the heater without causing a build-up of carbon monoxide. A warning label was affixed inside the cabinet heater in the space occupied by the liquified petroleum gas bottle. There was an absence of a visible warning label on the outside of the heater. It was not obvious to all potential users of the heater that the heater could only be used safely in a room of sufficient dimension. The risk applies particularly so in the case of rented cottages and similar premises such as ████████ ”

    Source location

    Thomas Oliver HILL · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Request that the relevant British Standards Institution committee review warning placement and content requirements for portable gas appliances under foreseeable conditions of use.

    Verbatim wording from the response

    “In addition, in light of the risks identified in this case, OPSS has written to the British Standards Institution, the UK’s standards-making body, to request the relevant committee(s) for BS EN 449:2002 +A1:2007 review the standard in relation to the placement and content of warnings on portable gas appliances, when considering all conditions of reasonably foreseeable use.”

    Source location

    Response from Product Safety & Standards
    Page 2 · response
    Published 30 July 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    There is no evidence that the product’s ventilation warning failed the applicable regulatory and voluntary standard requirements at the time.

    Verbatim wording from the response

    “The 1995 Regulations and the voluntary standard for dedicated liquefied petroleum gas appliances (BS EN 449:2002) are not prescriptive about the location of warnings. There is no evidence to suggest that the warning on this specific product regarding sufficient ventilation did not meet the requirements of the regulations and the voluntary standard at the time. I understand the warning directed users to the product’s instructions, but these were not available to the tenants of the property.”

    Source location

    Response from Product Safety & Standards
    Page 2 · response
    Published 30 July 2025

    Open published response
  3. Dorset

    AI-generated summary

    Philip Lesnes · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Philip Lesnes, who was living in a care home and had dementia, was found with denture adhesive gel in his mouth, ears and nose on 23 June 2024. His breathing became laboured, he was taken to hospital, and he died that day; the inquest recorded choking and inhalation of adhesive gel among the medical causes of death. Concerns included the product’s choking risk, its potential use by older people or people with cognitive decline, the need to consider it in care-home risk assessments, and the absence of choking warnings on its packaging or leaflet.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Absence of choking-risk warnings on adhesive gel product packaging and information leaflets

    Wider context from the report

    “2. I have concerns with regard to the following: i. The choking risk which this product poses. The qualities of the product are such that a thick adhesive gel can become lodged deep into the respiratory system and can be extremely difficult to remove ii. Such a product is likely to be used by the older generation and those who may be suffering from a decline of brain functioning. iii. Such a product should be considered as part of any risk assessment for those living in a care home setting. iv. There is no warning on the product packaging or on the enclosed information leaflet as to the risk of choking. ”

    Source location

    Philip Lesnes · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Raising denture adhesive packaging risks with product manufacturers is outside the respondent’s remit.

    Verbatim wording from the response

    “I note you have requested the Chief Executive Officer (CEO) of Fixodent should consider placing a warning on packaging so it is clear ingestion of the product is a potential risk. It is important to consider brands beyond just Fixodent (the CEO of which is listed as the other named respondent in the Regulation 28 report). There are several brands of denture adhesive gel available which will potentially carry the same choking risk due to the substance consistency. The patent safety leaflets of two popular brands of denture adhesive were reviewed and neither contained choking as a hazard, though they do advise what to do in the event of ingesting or inhaling. It is not within the CQC’s remit to raise this issue with the CEOs of these companies, so further action may be required by HM Coroner and/or the Office for Product Safety and Standards.”

    Source location

    Response from CQC
    Page 1 · response
    Published 27 February 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Further action on denture adhesive packaging risks may be required by the coroner or Office for Product Safety and Standards.

    Verbatim wording from the response

    “I note you have requested the Chief Executive Officer (CEO) of Fixodent should consider placing a warning on packaging so it is clear ingestion of the product is a potential risk. It is important to consider brands beyond just Fixodent (the CEO of which is listed as the other named respondent in the Regulation 28 report). There are several brands of denture adhesive gel available which will potentially carry the same choking risk due to the substance consistency. The patent safety leaflets of two popular brands of denture adhesive were reviewed and neither contained choking as a hazard, though they do advise what to do in the event of ingesting or inhaling. It is not within the CQC’s remit to raise this issue with the CEOs of these companies, so further action may be required by HM Coroner and/or the Office for Product Safety and Standards.”

    Source location

    Response from CQC
    Page 1 · response
    Published 27 February 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing compliance, clear usage instructions and post-market surveillance are considered sufficient, so no product or packaging changes are proposed.

    Verbatim wording from the response

    “It is important to clarify that Fixodent products fully comply with EU and UK medical device regulations. We provide clear usage instructions on the product, its packaging and the accompanying leaflet. They are safe and do not pose a choking risk when used as intended and directed, as supported by Mr. Jones' previous experience with denture adhesive cream.”

    Source location

    Response from Procter and Gamble UK
    Page 1 · response
    Published 27 February 2025

    Open published response
  4. Surrey

    AI-generated summary

    DAVID CHARLES MITCHENER · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    David Mitchener was admitted to East Surrey Hospital with hypercalcaemia on 10 May 2023 and died there on 20 May 2023. The substantive concerns were the potentially serious risks of excessive vitamin supplement use, the absence of appropriate dosage guidance and warnings, and food labelling requirements that did not require these risks to be stated on the packaging.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Food labelling requirements failing to require warnings about risks and side effects on packaging

    Wider context from the report

    “(1) Vitamin supplements can have potentially very serious risks and side effects when taken in excess (2) Current food labelling requirements do not require these risks and side effects to be written on the packaging. (3) Absence of appropriate warnings and guidance about dosage ”

    Source location

    DAVID CHARLES MITCHENER · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review product operations and labelling following the inquest.

    Verbatim wording from the response

    “The Company hopes that the above information provides reassurance to HM Coroner and Mr Mitchener’s family that it operates in a safe and compliant manner and has at its heart, the safety of its consumers. Indeed, following the Inquest, the Company reviewed its operations including the labelling of its products generally and remains confident that it continues to comply with the applicable law and guidance, and is industry standard.”

    Source location

    Response from Save on Supplements ltd on behalf of NaturPlus UK
    Page 3 · response
    Published 22 February 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Contact relevant local authorities to ascertain whether the product complies with food supplement requirements.

    Verbatim wording from the response

    “The FSA will raise your report at the next cross-government Food Supplements Working Group, which will take place in April, and we will ensure full consideration will be given to the matters of concern you have highlighted. We intend to contact the relevant local authorities to ascertain whether the product is in compliance with food supplements requirements. We would be grateful if you could share any product details or packaging that you have, which will inform and aid our interactions with the relevant local authorities.”

    Source location

    Response from Food Standard Agency
    Page 2 · response
    Published 22 February 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Overarching regulation of vitamin supplements is better addressed by the Food Standards Agency and Department of Health and Social Care.

    Verbatim wording from the response

    “In your Report, you raised three Matters of Concern. We respectfully suggest that some of the Matters of Concern relating to the overarching regulation of vitamin supplements are better addressed by the Food Standards Agency and the Department of Health and Social Care. We note that you have also addressed the Report to these organisations who no doubt will respond directly.”

    Source location

    Response from Save on Supplements ltd on behalf of NaturPlus UK
    Page 1 · response
    Published 22 February 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing legal compliance, guidance adherence, consumer information and product labelling are considered sufficient to support safe Vitamin D supplement use.

    Verbatim wording from the response

    “The Company sells food supplement products, including those containing Vitamin D, via an online business platform. In the conduct of its business, the Company is compliant with the applicable law and available guidance.”

    Source location

    Response from Save on Supplements ltd on behalf of NaturPlus UK
    Page 1 · response
    Published 22 February 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Policy advice on supplement composition and labelling in England is assigned to the Department of Health and Social Care.

    Verbatim wording from the response

    “The composition and labelling of supplements is devolved and policy advice to Ministers on it rests with a number of different bodies which includes the Department for Health and Social Care (DHSC) in England, Welsh Government, the FSA in Wales and Northern Ireland, and with Food Standards Scotland in Scotland. As your report is in”

    Source location

    Response from Food Standard Agency
    Page 1 · response
    Published 22 February 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Amending key supplement legislation is assigned to Ministers in the respective nations.

    Verbatim wording from the response

    “relation to England, we understand that DHSC is providing a response in respect to their policy. Powers to amend the key legislation in this area sits with Ministers in the respective nations. Co-ordination of policy takes place through a number of groups including the Food Supplements Working Group, which the FSA chairs.”

    Source location

    Response from Food Standard Agency
    Page 2 · response
    Published 22 February 2024

    Open published response
  5. Milton Keynes

    AI-generated summary

    Rohan GODHANIA · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Rohan GODHANIA became unwell after consuming a high-protein drink on 15 August 2020, was admitted to hospital, and died on 18 August 2020 from Ornithine Transcarbamylase Deficiency. The report identifies concerns about inconsistent NHS classification of teenagers aged 16–18 and a lack of emergency-department guidance on ammonia testing for patients presenting in extremis with an unknown cause.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of high-protein supplement and drink labels to provide adequate warnings and safety information for people with urea cycle disorders

    Wider context from the report

    “High protein supplements and drinks are easily accessible to the general public, yet their labels fail to adequately inform consumers about the potential dangers posed to individuals with urea cycle disorders, such as Ornithine Transcarbamylase (OTC) deficiency. This genetic disorder can lead to severe medical emergencies, requiring immediate medical intervention to prevent life-threatening complications. This disorder can be triggered by the sudden increased ingestion of protein. Consideration should be given as to whether the labels should prominently display a warning about the potential risks for individuals with an undiagnosed urea cycle disorder and include clear and concise information on symptoms of this and the importance of seeking immediate medical advice. ”

    Source location

    Rohan GODHANIA · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Share the coroner’s report with DHSC to support consideration of additional food labelling.

    Verbatim wording from the response

    “As noted above, nutritional and broader health advice on whether and how it could be included on labelling is the responsibility of DHSC in England. We will share your report with DHSC so that they can more fully consider your recommendation for additional labelling. It may also be worth you writing to them directly, copied to DEFRA as the department responsible for food compositional standards and labelling”

    Source location

    Response from Food Standards Agency
    Page 2 · response
    Published 6 September 2023

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Responsibility for nutritional and broader health advice on additional food labelling rests with DHSC in England.

    Verbatim wording from the response

    “The FSA has responsibility for food and feed safety and hygiene in England and Wales, food compositional standards and labelling policy in Northern Ireland and Wales, and nutritional health claims and nutritional labelling in Northern Ireland. In England responsibility for food compositional standards and labelling policies rests with the Department of Environment, Food and Rural Affairs (DEFRA). Nutritional health claims and nutritional labelling responsibility rests with the Department of Health and Social Care (DHSC) in England and the Welsh Government in Wales.”

    Source location

    Response from Food Standards Agency
    Page 2 · response
    Published 6 September 2023

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Responsibility for food compositional standards and labelling rests with DEFRA in England.

    Verbatim wording from the response

    “The FSA has responsibility for food and feed safety and hygiene in England and Wales, food compositional standards and labelling policy in Northern Ireland and Wales, and nutritional health claims and nutritional labelling in Northern Ireland. In England responsibility for food compositional standards and labelling policies rests with the Department of Environment, Food and Rural Affairs (DEFRA). Nutritional health claims and nutritional labelling responsibility rests with the Department of Health and Social Care (DHSC) in England and the Welsh Government in Wales.”

    Source location

    Response from Food Standards Agency
    Page 2 · response
    Published 6 September 2023

    Open published response
  6. Surrey

    AI-generated summary

    Angela Jean Kearn · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Angela Jean Kearn, aged 63, collapsed and died while snorkelling in Egypt on 13 January 2020. The inquest identified immersion pulmonary oedema as the cause of death, with hypertension, hormone replacement therapy and use of a full-face snorkel mask each contributing more than minimally. Concerns included limited medical awareness of immersion pulmonary oedema and insufficiently publicised safety warnings about using full-face snorkel masks with cardiovascular or respiratory conditions.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide sufficiently prominent warnings about full-face mask risks to affected users

    Wider context from the report

    “ix.) Decathlon have recently updated their website in the United Kingdom to include the following, “It is not recommended to use this product if you have any ongoing respiratory or cardiovascular issues including but not limited to chest infection, asthma, high/raised blood pressure (hypertension), heart disease or angina etc. If you have any doubts or questions relating to this please check with your medical practitioner.” The same additional wording is being translated and added to all websites of the company. x.) The packaging of the mask has been revised to show a pictogram to warn against use of the mask by those with heart or other cardiovascular conditions. xi.) The concern is that many million of the full face masks have been sold and the safety concerns about their use by those with ongoing cardiovascular and respiratory issues has not been widely publicised or brought to the attention of those who already own the masks. Those purchased before 2017 had no warning in relation to these matters and the warning included in the instructions from 2017 inwards was not prominent nor sufficient to alert prospective purchasers to the hazards of use which have now been identified. ”

    Source location

    Angela Jean Kearn · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Product safety falls outside the organisation’s functions and grant-funded scope, so it cannot act on the reported issues.

    Verbatim wording from the response

    “National Trading Standards (NTS) is not able to act on the issues raised in this report. NTS is a grant giving body that utilises Government grants to commission specified elements of Trading Standards related work from local authorities. Product safety does not fall within the scope of NTS. We do not receive any grants to commission work in this area. Issues surrounding product recalls and the Government lead for the safety of consumer products lies with the Office for Product Safety and Standards (part of the Department for Business and Trade). They work with local authorities on product recalls and we would recommend that, if it has not already been sent to them, that this report is sent to the Chief Executive of OPSS to respond.”

    Source location

    Response from National Trading Standards
    Page 1 · response
    Published 31 March 2023

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The Office for Product Safety and Standards holds responsibility for product recalls and consumer product safety matters.

    Verbatim wording from the response

    “National Trading Standards (NTS) is not able to act on the issues raised in this report. NTS is a grant giving body that utilises Government grants to commission specified elements of Trading Standards related work from local authorities. Product safety does not fall within the scope of NTS. We do not receive any grants to commission work in this area. Issues surrounding product recalls and the Government lead for the safety of consumer products lies with the Office for Product Safety and Standards (part of the Department for Business and Trade). They work with local authorities on product recalls and we would recommend that, if it has not already been sent to them, that this report is sent to the Chief Executive of OPSS to respond.”

    Source location

    Response from National Trading Standards
    Page 1 · response
    Published 31 March 2023

    Open published response
  7. Northamptonshire

    AI-generated summary

    Andrew Cook · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Andrew Cook suffered anaphylaxis and cardiac arrest during percutaneous coronary intervention at Kettering General Hospital on 31 March 2019, and resuscitation was unsuccessful. The concerns included under-reporting and limited research into PEG allergy, lack of clear information about PEG in medical equipment and its dose and molecular weight, and inconsistent PEG nomenclature that could cause confusion for clinicians.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure of medical product information to clearly identify PEG existence, dose and molecular weight

    Wider context from the report

    “(2) Whether the existence, dose and molecular weight of PEG should be made clear on medical product information (such as the Instructions For Use, data sheets, packaging and marketing information). The existence of PEG in the equipment (in this case, the Sion and Sion Blue guidewires manufactured by Asahi Intecc) was not apparent from the packaging or product information available to the clinicians. PEGs are available in various molecular weights. There was expert evidence that reaction to PEG may depend on the dose and exact molecular weight to which an individual is exposed. It was acknowledged that labelling can have negative effects and therefore needs to be considered with care. Labelling also requires coordination with other national regulators. ”

    Source location

    Andrew Cook · Prevention of Future Deaths report
    Page 1 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Work with UK Approved Bodies to communicate the importance of clear PEG labelling.

    Verbatim wording from the response

    “1. The MHRA will work with UK ABs to communicate the importance of appropriate clear labelling with respect to PEG.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 4 · response
    Published 3 August 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Engage medical-device manufacturers and other stakeholders to develop clear PEG/macrogol labelling guidelines.

    Verbatim wording from the response

    “2. We will continue to engage with relevant stakeholders, in particular the medical device manufacturers, to develop clear guidelines on labelling requirements for PEG/macrogol.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 4 · response
    Published 3 August 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review requirements for disclosing PEG molecular weight and quantity, consulting patient representatives, clinical experts and industry.

    Verbatim wording from the response

    “3. Concerning the need for additional detail on the labelling of PEG regarding the its molecular weight and amount/quantity used, we will need to undertake a longer-term programme of review. The MHRA will discuss these points with patient representative groups, clinical experts, and industry.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 4 · response
    Published 3 August 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Appraise UK medical-device and medicines legislation on minimum ingredient-labelling requirements.

    Verbatim wording from the response

    “4. The MHRA will continue to perform ongoing appraisal of the current medical devices and medicines UK legislation with regards to expectations on minimum labelling requirements relating to ingredients.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 4 · response
    Published 3 August 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Continue reviewing PEG exposure data, seek external expert views and use the findings to develop labelling advice for devices and medicines.

    Verbatim wording from the response

    “Conclusion The MHRA will continue to collect and review information from a range of data sources on PEG exposure including via our adverse incident (Yellow Card) reporting system and database, as well as independent scientific publications. This information will form part of an ongoing review in which we will seek views of external experts, that will aid us in the development of labelling advice for PEG in medical devices and medicines, specifically the balance of benefits and risks to patients and other users of medical devices.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 5 · response
    Published 3 August 2021

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Appraise feedback from the public consultation, including feedback on proposed medical-device labelling requirements.

    Verbatim wording from the response

    “The MHRA will appraise the feedback received from the public consultation of the UK medical devices legislation including the Chapter relating to labelling so that we may create a world-leading regime that continues to prioritise patient safety. These actions combined with the measures above, will minimise risk associated with PEG allergy while ensuring continued access to devices from those patients who will benefit.”

    Source location

    2021-0258-Response-from-MHRA_Published
    Page 5 · response
    Published 3 August 2021

    Open published response
  8. Birmingham and Solihull

    AI-generated summary

    Suzanna Jayne Bull · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Dr Suzanna Bull died after being struck and dragged beneath a 32-tonne lorry while cycling in a designated bus/cycle lane on 9 October 2017. The lorry driver's aftermarket dashboard tray and items placed on it obscured the front and nearside view, creating a blind spot. The substantive concerns were the absence of warnings that such trays can create blind spots and should not be fitted while a vehicle is moving.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of warnings on dashboard trays against fitting them in moving vehicles

    Wider context from the report

    “1. The fact that the tray creates a blind spot may not be apparent to users. There is no warning on the tray to say that it can create a blind spot when fixed in place whilst the vehicle is moving. Consideration should be given to placing a clear warning on the tray that it should not be fitted. 2. There is no general warning to lorry manufacturers and haulage firms to advise against the use of such trays in a moving vehicle due to the blind spot it creates. Consideration should be given to sending out a warning to all manufacturers and users to highlight the concern. 3. There is no warning on the dashboard tray to say that it should only be fitted when the vehicle is parked up and stationary. ”

    Source location

    Suzanna Jayne Bull · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Highlight the report’s safety concerns at the Heavy Vehicle Industry Forum and ask attendees to pass the information to their members.

    Verbatim wording from the response

    “On the 6 May 2020 we propose to highlight the areas of concern in your report to attendees at our regular Heavy Vehicle Industry Forum. This is a meeting we host with attendees including industry trade bodies, such as the Society of Motor Manufacturers and”

    Source location

    2019-0404-Response-from-Driver-and-Vehicle-Standards-Agency-Redacted
    Page 1 · response
    Published 29 December 2019

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update commercial-vehicle safety guidance to warn drivers against placing objects in lorries that restrict their view.

    Verbatim wording from the response

    “We publish information on GOV.UK about keeping commercial vehicles safe to drive. Our Guide to Maintaining Roadworthiness is also published on GOV.UK. The Guide includes information on a driver's daily walkaround checks, including ensuring no objects get in the way of their front view. A short video shows some of the checks a driver should do during their daily check. This includes checking there is a clear view through the windscreen. We will be updating this guidance to warn drivers against putting objects in their lorry, which restrict their view.”

    Source location

    2019-0404-Response-from-Driver-and-Vehicle-Standards-Agency-Redacted
    Page 2 · response
    Published 29 December 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The Department lacks authority to require warning messages on aftermarket dashboard trays about visibility risks during driving.

    Verbatim wording from the response

    “Further to the Regulation 28 Report you listed some matters of concerns and your opinion that action should be taken. Several actions are planned, although the Department does not have a locus to require warning messages to be placed on aftermarket dashboard trays to indicate they may block visibility during driving (particularly if substantial objects are put on them).”

    Source location

    2019-0404-Response-from-the-Department-for-Transport-Redacted
    Page 1 · response
    Published 29 December 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The respondent lacks authority to require warning messages on aftermarket dashboard trays.

    Verbatim wording from the response

    “We do not have the authority to require warning messages to be put on aftermarket dashboard trays. We can, however, highlight the matters of concern to large goods vehicle (LGV) drivers.”

    Source location

    2019-0404-Response-from-Driver-and-Vehicle-Standards-Agency-Redacted
    Page 1 · response
    Published 29 December 2019

    Open published response
  9. Manchester South

    AI-generated summary

    Savannah-Rose Michelle Owen · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Savannah-Rose Michelle Owen was a healthy baby born on 16 February 2018 who fell asleep on a nursing pillow on a sofa at home on 22 April 2018 and later became unresponsive. Resuscitation attempts were unsuccessful, and the post-mortem found no cause of death, with the death recorded as due to natural causes. Concerns included the lack of specific safety regulation for multi-purpose nursing pillows, potentially misleading imagery and warnings, the warning label not being attached to the pillow, and uncertainty about whether community health professionals were highlighting the risks of unsupervised sleeping on such pillows.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Misleading warning leaflet imagery about leaving babies unattended on multi-purpose nursing pillows

    Wider context from the report

    “3. On the warning/information leaflet were 5 pictures of a baby positioned on the pillow. In only 2 images was the baby with an adult. On the other 3 the baby was alone. The inquest was told that this could be misleading as to the importance of never leaving a baby unattended on the pillow; and ”

    Source location

    Savannah-Rose Michelle Owen · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to keep safety warnings attached to multi-purpose nursing pillows through resale or recycling

    Wider context from the report

    “4. The warning label was not attached to the item therefore; once the package had been opened, there was a high risk that the warning label would be lost. On resale/recycling of baby items this meant that second hand users/purchasers were unlikely to see the warning. ”

    Source location

    Savannah-Rose Michelle Owen · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Refer concerns about the nursing pillow to the Office for Product Safety and Standards’ Product Safety Enforcement Team.

    Verbatim wording from the response

    “I have passed your concerns regarding the nursing pillow on to OPSS’s Product Safety Enforcement Team but in order to investigate further they have asked that any details you have of the specific product involved, including information about the distributor be shared with them. If you have any further information that would assist their assessment, I would be grateful if you could pass it directly to Graham Russell, Chief Executive, OPSS, Victoria Square House, Birmingham B2 4AJ. This would allow OPSS to work with Local Authority Trading Standards to determine whether further action is needed, based on all the evidence available.”

    Source location

    2018-0367-Response-by-Department-for-Business-Energy-Industrial-Strategy
    Page 2 · response
    Published 10 May 2019

    Open published response
  10. West Yorkshire (Western)

    AI-generated summary

    Brian Leonard Bicat · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Brian Leonard Bicat sustained severe burns at home on 22 September 2017 when his dressing gown caught fire while he was smoking a cigarette. He died later that day from his extensive cutaneous burns, with evidence indicating that paraffin-based emollient creams and ointments increased the speed and intensity of the fire. The principal concerns were that low-paraffin emollients may pose a fire hazard, that warnings were not displayed consistently on packaging or communicated by healthcare professionals, and that related prescribing alerts and incident data were inconsistent or incomplete.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to display fire-risk warnings on all product packaging

    Wider context from the report

    “Warnings of such risks are not displayed on all product packaging ”

    Source location

    Brian Leonard Bicat · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Issue safety reminders and warnings to healthcare professionals about fire risks from paraffin-based emollients.

    Verbatim wording from the response

    “In March 2008 MHRA Devices issued a reminder to healthcare professionals of the potential risks associated with paraffin based emollients, as highlighted by the work of the National Patient Safety Agency (NPSA) in 2007. This reminder was in the form of a “One Liner” which was published in issue 56. Since, at that time, as no adverse incident reports had been received, it was not considered necessary to issue any further communication.”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Write to manufacturers to include emollient fire risks in product risk analyses and provide packaging or instructions-for-use warnings.

    Verbatim wording from the response

    “However, in addition, we have written to manufacturers to raise awareness of this potential risk. This highlighted the need for the risk of fire to be included in their product risk analysis and ensuring warnings of the potential risk were placed either on packaging or included in the device’s instructions for use. We have previously issued warnings regarding the dangers around smoking and bed fires (MDA/2013/073).”

    Source location

    2018-0277-Response-by-MHRA
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Complete a Hydromol product-labelling review to improve warning prominence, clarity, content and consistency across paraffin concentrations.

    Verbatim wording from the response

    “We have completed a product labelling review to improve prominence, clarity and content as well as ensuring consistency across the Hydromol range, regardless of paraffin content. The revised product labelling, website and promotional materials is expected to be available throughout the remainder of 2018 and 2019.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Add a fire-risk warning to Hydromol product labelling, explaining ignition risks involving contaminated dressings, clothing and bedding.

    Verbatim wording from the response

    “The labelling now states:”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish revised Hydromol labelling, website content and promotional materials incorporating improved fire-risk information.

    Verbatim wording from the response

    “We have completed a product labelling review to improve prominence, clarity and content as well as ensuring consistency across the Hydromol range, regardless of paraffin content. The revised product labelling, website and promotional materials is expected to be available throughout the remainder of 2018 and 2019.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 1 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Undertake a cross-functional expert assessment of Hydromol labelling using information from the incident to identify further improvement opportunities.

    Verbatim wording from the response

    “We will undertake an assessment of the labelling throughout the remainder of this year, this activity will review all information from this event to determine any further opportunities for improvement of the current labelling. The assessment will be performed by a cross functional group of experts who have knowledge and experience of Hydromol and its use. We will implement any required changes to the product, product labelling or promotional materials which the risk assessment identifies. We will also apply required labelling amendments to marketed paraffin containing products, regardless of paraffin content.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review proposed Hydromol labelling changes with user groups to confirm that the intended safety message is understandable.

    Verbatim wording from the response

    “Furthermore, any proposed changes to the labelling will be reviewed by user groups who will support us in ensuring the intended message is understandable. We are also engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are clearly stated on our labelling.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Engage West Yorkshire Fire Service to ensure Hydromol labelling clearly explains the mechanisms of fire risk.

    Verbatim wording from the response

    “Furthermore, any proposed changes to the labelling will be reviewed by user groups who will support us in ensuring the intended message is understandable. We are also engaging with West Yorkshire Fire Service to ensure the mechanisms of risk are clearly stated on our labelling.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Work with the MHRA and PAGB to develop a consolidated fire-risk warning for all relevant product packaging across the industry.

    Verbatim wording from the response

    “We are proactively working with the MHRA and PAGB to ensure a consolidated warning is displayed on all product packaging, across industry. And we further commit to revisiting warnings on the product packaging, or any supporting processes, if additional information from the MHRA, trade bodies or any other expert groups becomes available.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 2 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Reclassify Diprobase Cream as a Class 1 medical device and complete the associated conformity assessment.

    Verbatim wording from the response

    “However, Bayer is in the process of re-classifying Diprobase Cream as a Class 1 medical device under the Medical Devices Regulations 2002 and has conducted a conformity assessment in accordance with such Regulations. In compliance with the Regulations, Bayer may apply warnings to the labelling of medical devices without external regulatory approval. When the re-classified product is launched in the UK (anticipated around February 2019) Diprobase Cream will include the warning “Keep fabric which has been in contact with this product away from sources of fire including lit cigarettes”. The warning will be visible on the external labelling/packaging of the product as well”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 6 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Launch Diprobase Cream with a fire-source warning on external packaging and in the patient information leaflet.

    Verbatim wording from the response

    “However, Bayer is in the process of re-classifying Diprobase Cream as a Class 1 medical device under the Medical Devices Regulations 2002 and has conducted a conformity assessment in accordance with such Regulations. In compliance with the Regulations, Bayer may apply warnings to the labelling of medical devices without external regulatory approval. When the re-classified product is launched in the UK (anticipated around February 2019) Diprobase Cream will include the warning “Keep fabric which has been in contact with this product away from sources of fire including lit cigarettes”. The warning will be visible on the external labelling/packaging of the product as well”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 6 · response
    Published 30 October 2018

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Changes to medicinal-product labelling require MHRA approval, which will not be granted until its labelling review is complete.

    Verbatim wording from the response

    “In 2017, the MHRA commenced a review of the labelling of paraffin-containing emollients and the instructions for use provided in relation to such products, with a view to determining consistent warnings to apply to all such products, where appropriate. Bayer has co-operated fully with this review, but understands that it has not yet been completed.”

    Source location

    2018-0277-Response-by-Alliance-Pharmaceuticals-and-Bayer
    Page 6 · response
    Published 30 October 2018

    Open published response
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Data last updated 7 September 2026