18 Sep 2017 Kathleen Erica Holme · Prevention of Future Deaths report Cumbria
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Concerns raised 2
Failure of naked-flame danger warnings to be sufficiently large and prominent View source Absence of naked-flame danger warnings on the body of the automatic air freshener View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
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AI-generated summary
Kathleen Erica Holme · 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
Kathleen Erica Holme died after a fire at her home in the early hours of 26 March 2017, having been rescued from the property. The fire involved candles and a Glade automatic air freshener, and she died from burns and smoke inhalation. Concerns were raised about the extent and prominence of warnings about using the air freshener near naked flames, including the lack of warnings on the device itself.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of naked-flame danger warnings to be sufficiently large and prominent
Wider context from the report “(2) Whilst there are both warning signs and wording on the box containing a new spray and on the aerosol to be fitted to it, I am concerned that the words warning of the dangers of use near a naked flame is not sufficiently large and prominent to draw the dangers to a users attention .
” Source location Kathleen Erica Holme · Prevention of Future Deaths report
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Absence of naked-flame danger warnings on the body of the automatic air freshener
Wider context from the report “(3) There were no warning signs on the body of the automatic air freshener. Once the box containing the new air freshener was discarded a user would have only the information printed on the aerosol as a warning.
” Source location Kathleen Erica Holme · Prevention of Future Deaths report
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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 Apply high-contrast safety warnings, hazard pictograms and labelling to the refill canister and product packaging.
Verbatim wording from the response “To educate and warn consumers about the dangers of using the air freshener refill canister near to naked flames, we mark the refill with safety warnings and labelling.” Source location 2017-0212-Response-by-SC-Johnson
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Assess the product labelling against applicable regulatory requirements, guidelines and industry standards.
Verbatim wording from the response “The labelling on the Glade® Automatic Air Freshener has been assessed against the regulatory requirements and guidelines and industry standards to address Concerns 2 and 3 in the Report:” Source location 2017-0212-Response-by-SC-Johnson
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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 packaging and refill labelling is considered sufficient; labelling the dispenser is not required and could mislead consumers.
Verbatim wording from the response “The labelling on the Glade® Automatic Air Freshener has been assessed against the regulatory requirements and guidelines and industry standards to address Concerns 2 and 3 in the Report:” Source location 2017-0212-Response-by-SC-Johnson
Open published response
21 Jul 2017 Pauline Taylor · Prevention of Future Deaths report West Yorkshire (West)
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Concerns raised 1
Failure to display fire-risk warnings on all product packaging View source
This report raised 8 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Locala Community Partnerships Medicines and Healthcare products Regulatory Agency PAGB
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 6
PAGB
Develop consistent, clear warning wording for paraffin-containing emollient packaging and patient information.
View source
PAGB
Submit proposed warning wording for user-testing to assess whether consumers understand it clearly.
View source
PAGB
Work with the Medicines and Healthcare products Regulatory Agency to implement a consistent standard warning on packaging and patient information leaflets after user-testing.
View source
Medicines and Healthcare products Regulatory Agency
Undertake an in-depth review of emollient instructions for use and reported adverse incidents.
View source
Medicines and Healthcare products Regulatory Agency
Work with manufacturers to raise awareness of emollient fire risks.
View source
Medicines and Healthcare products Regulatory Agency
Ask manufacturers and notified bodies to review products and undertake relevant fire-risk assessments.
View source See 3 more actions
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AI-generated summary
Pauline Taylor · 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
Pauline Taylor, who was bedbound and living alone, died in her home after a fire developed around her bed on 30 May 2015. The report identified concerns about the fire risks of low-paraffin emollient creams, limited warnings and awareness of those risks, the contribution of the airflow mattress, and the absence of a further risk assessment after her circumstances changed.
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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 “(2) Warnings of such risks are not displayed on all product packaging.
” Source location Pauline Taylor · Prevention of Future Deaths report
Open source report
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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 Develop consistent, clear warning wording for paraffin-containing emollient packaging and patient information.
Verbatim wording from the response “In addition to ensuring warning statements are included on the packaging of all appropriate products, it is imperative that these warnings are consistent as well as clear and meaningful to members of the public who will read them. PAGB has been working with its member companies to develop wording which we will submit for user-testing to ensure its clarity.” Source location 2017-0330-Response-by-PAGB
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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 Submit proposed warning wording for user-testing to assess whether consumers understand it clearly.
Verbatim wording from the response “In addition to ensuring warning statements are included on the packaging of all appropriate products, it is imperative that these warnings are consistent as well as clear and meaningful to members of the public who will read them. PAGB has been working with its member companies to develop wording which we will submit for user-testing to ensure its clarity.” Source location 2017-0330-Response-by-PAGB
Open published response
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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 Medicines and Healthcare products Regulatory Agency to implement a consistent standard warning on packaging and patient information leaflets after user-testing.
Verbatim wording from the response “Following the results of user-testing, PAGB will work with MHRA to ensure there is consistency in implementation of a standard warning for packaging and patient information leaflets.” Source location 2017-0330-Response-by-PAGB
Open published response
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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 an in-depth review of emollient instructions for use and reported adverse incidents.
Verbatim wording from the response “It is recognised that there are differences in the labelling of these products and in light of this during 2017, both Medicines and Devices parts of MHRA are undertaking an in-depth review of instructions for use and reported adverse incidents.” Source location 2017-0330-Response-by-MHRA
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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 manufacturers to raise awareness of emollient fire risks.
Verbatim wording from the response “Additionally, we have worked with manufacturers to raise awareness of this potential risk. This work highlighted the need for 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 2017-0330-Response-by-MHRA
Open published response
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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 Ask manufacturers and notified bodies to review products and undertake relevant fire-risk assessments.
Verbatim wording from the response “In Spring 2017 MHRA wrote to UK manufacturers of Class I medical devices (the lowest risk category) directly and asked them to undertake a review of their products. In addition, we asked the UK Notified Bodies to ensure that a review and risk assessment was undertaken by manufacturers of higher risk classification medical devices.” Source location 2017-0330-Response-by-MHRA
Open published response
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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 Warnings on emollient packaging and to the general public are matters for other recipients with a broader remit.
Verbatim wording from the response “This is the Response of Locala Community Partnerships. As an organisation we have considered the content of your report very carefully. We note that at section 5 you have raised a number of matters of concern relating to zerobase and other emollient creams which whilst containing potentially a relatively low level of paraffin, still pose a potential fire hazard risk. We note the recommendations concerning warnings on the packaging and to members of the public at large, who as you note are able to purchase many such creams over the counter. Locala would support the raising of awareness in this area and if it is permissible, would be interested to see the responses that you obtain from the other recipients of your Regulation 28 report that have a broader remit.” Source location 2017-0330-Response-by-Locala_Redacted
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26 Aug 2016 Raymond Charles Woodward · Prevention of Future Deaths report Birmingham and Solihull
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Concerns raised 1
Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response
Medicines and Healthcare products Regulatory Agency
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 4
Medicines and Healthcare products Regulatory Agency
Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.
View source
Medicines and Healthcare products Regulatory Agency
Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.
View source
Medicines and Healthcare products Regulatory Agency
Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.
View source
Medicines and Healthcare products Regulatory Agency
Request the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.
View source See 1 more action
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AI-generated summary
Raymond Charles Woodward · 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
Raymond Charles Woodward suffered a cardiac arrest and died on 19 February 2016 while undergoing a colonoscopy after Buscopan was administered. The report identified concerns that the risk of adverse reactions to Buscopan in patients with coronary artery disease was not widely known and that existing prescribing information did not specifically address ischaemic heart disease.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of intravenous Buscopan cardiovascular warnings to specifically encompass ischaemic heart disease
Wider context from the report “(2) The SPC relating to the use of intravenous Buscopan references the following in relation to the cardiovascular system – ‘Buscopan Ampoules should be used with caution in conditions characterised by tachycardia such as thyrotoxicosis, cardiac insufficiency or failure and in cardiac surgery where it may further accelerate the heart rate’.
(3) The term ‘cardiac insufficiency’ is unwieldy and does not immediately relate to a specific diagnosis, lacks specificity and does not necessarily encompass those patients with ischaemic heart disease.
” Source location Raymond Charles Woodward · Prevention of Future Deaths report
Open source report
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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 Revise the Buscopan Ampoules Summary of Product Characteristics to strengthen warnings about serious adverse reactions in patients with cardiac disease.
Verbatim wording from the response “Further to my letter dated 7 December 2016 regarding the inquest into the death of Raymond Charles Woodward, I can confirm that the Summary of Product Characteristics (SmPC) for Buscopan Ampoules has been updated to more clearly communicate and minimise this risk of serious adverse reactions in patients with underlying cardiac disease. Section 4.4 of the SmPC has been revised with the following warning:” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
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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 Communicate the revised Buscopan safety recommendations to healthcare professionals through the MHRA Drug Safety Update newsletter.
Verbatim wording from the response “We have also communicated these new recommendations to healthcare professionals through an article in our MHRA newsletter, Drug Safety Update, which is available at https://www.gov.uk/drug-safety-update” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency2
Open published response
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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 Analyse reported UK deaths suspected to involve Buscopan Ampoules and review the current product information to determine necessary regulatory action.
Verbatim wording from the response “To determine what regulatory action, if any, is required with respect to Buscopan Ampoules we have analysed all the reported deaths in the UK that were suspected as being caused by Buscopan Ampoules and reviewed the current product information.” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
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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 the Buscopan Ampoules licence holder to revise product information to clarify cardiac risks and recommend monitoring and readily available emergency equipment and trained personnel.
Verbatim wording from the response “Given that the risk of serious cardiac side effects due to Buscopan Ampoules is more likely in patients with cardiac conditions, such as coronary heart disease, we agree that the product information should be updated to more clearly communicate and minimise this risk in these patients. We have therefore written to the Company who hold the licence for Buscopan Ampoules and requested that they update the product information accordingly. The Company has agreed to revise the warning in section 4.4 of the SmPC which you highlighted as not adequately describing the risk in patients with coronary heart disease. The warning will recommend caution when using Buscopan Ampoules in patients with cardiac disease, including coronary heart disease, because of the risk of tachycardia, hypotension and anaphylaxis.” Source location 2016-0308-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Open published response
Concerns raised 1
Lack of fire-hazard warnings on E45 prescriptions and product packaging View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked responses
Medicines and Healthcare products Regulatory Agency RB
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 5
Medicines and Healthcare products Regulatory Agency
Add fire-risk label warnings to emollient products containing predominantly paraffin-based ingredients.
View source
Medicines and Healthcare products Regulatory Agency
Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.
View source
RB
Conduct an additional safety assessment and reassess flammability labelling across the E45 product portfolio.
View source
RB
Submit an MHRA variation application to add flammability warnings and safe-use guidance to specified E45 medicinal and cosmetic products.
View source
RB
Release the specified E45 medicinal and cosmetic products with revised labels containing flammability warnings and safe-use guidance.
View source See 2 more actions
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AI-generated summary
Michael Holyoake · 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
Michael Holyoake, who was bed bound with a terminal and inoperable brain tumour, died after a fire at his home while he was being cared for there. The fire was thought most likely to have involved his lighter and E45 emollient residue on his bedding and clothing, which acted as an accelerant. The principal concerns were a lack of awareness of E45’s flammability and the absence of fire hazard warnings on its prescription or packaging.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Lack of fire-hazard warnings on E45 prescriptions and product packaging
Wider context from the report “1. E45 is highly flammable as it is a paraffin based product, the residue of which acts as an accelerant. In this case there was a distinct lack of awareness of this fact, by the carers and the deceased. This was in part due to lack of communication by the GP but also due to the fact that there were no fire hazard warnings on the prescription or the product itself .
This product is widely available over the counter to the general public and commonly used for vulnerable individuals such as children and the elderly. Worryingly there would appear to be no warnings on the packaging that this is indeed highly flammable , with the potential risk of ignition.
” Source location Michael Holyoake · Prevention of Future Deaths report
Open source report
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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 fire-risk label warnings to emollient products containing predominantly paraffin-based ingredients.
Verbatim wording from the response “In 2009 on the basis of the evidence available at the time, the MHRA added label warnings to those emollient products which included predominantly paraffin based ingredients to warn patients and carers of the risks if used in large quantities of acting as an accelerant. The warning statement which appears on the outer packaging is:” Source location Response from Chief Fire Officers Association and MHRA
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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 Take regulatory action to require similar fire-risk warnings on all emollient medicines, including aqueous-based products such as E45 Cream.
Verbatim wording from the response “Aqueous-based products such as E45 Cream were not included in this review. In light of this case we will now take action to ensure all emollient medicines, including those aqueous based products such as E45 Cream carry a similar warning statement. We aim to have completed regulatory action by the end of the year and will accompany this with appropriate communications to relevant healthcare professionals including nurses to reinforce the warning and advice.” Source location Response from Chief Fire Officers Association and MHRA
Open published response
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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 Conduct an additional safety assessment and reassess flammability labelling across the E45 product portfolio.
Verbatim wording from the response “Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:” Source location 2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
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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 Submit an MHRA variation application to add flammability warnings and safe-use guidance to specified E45 medicinal and cosmetic products.
Verbatim wording from the response “Despite regularly assessing our products we have taken this tragedy as a reason to conduct an additional safety assessment and reassess the labelling across our entire E45 product portfolio in respect to its potential risk of flammability. As a result of our safety review, we will be submitting an application to the MHRA to update the labelling to include guidance on potential flammability, of the following medicinal product:” Source location 2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
Open published response
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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 Release the specified E45 medicinal and cosmetic products with revised labels containing flammability warnings and safe-use guidance.
Verbatim wording from the response “The below warning will be added to the product labelling:” Source location 2016-0163-Response-by-Reckitt-Benckiser-Group-Plc
Open published response
22 Jan 2016 Javaid Iqbal · Prevention of Future Deaths report Manchester West
View report summary
Concerns raised 1
Failure to provide a prominent warning about the risk of fatal carbon monoxide poisoning from indoor use View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Javaid Iqbal · 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
Javaid Iqbal, who was working alone as a security guard at a construction site, died after lighting charcoal in a wheelbarrow inside a portacabin when the generator failed and left him without heat or light. The concerns included inadequate response to his reports, insufficient cold-weather clothing, lack of clear instructions for lone working, and the need for written instructions and training concerning welfare, safe temperatures, clothing, and leaving the site.
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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 a prominent warning about the risk of fatal carbon monoxide poisoning from indoor use
Wider context from the report “(1) The packaging of the charcoal provides instructions which indicate it should not be used indoors. The warning is not given much prominence and does not draw attention to the risk of death from carbon monoxide poisoning if used indoors .
” Source location Javaid Iqbal · Prevention of Future Deaths report
Open source report
19 Jan 2016 Irene Anne Pearson · Prevention of Future Deaths report Manchester South
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Concerns raised 1
Failure to prominently communicate the danger of taking a hot bath whilst wearing the patch View source
This report raised 6 other concerns. They are not shown here because they do not form part of this recurring concern.
Stated actions An action is something a respondent says it has done, is doing, or plans to do in response to the concern raised. 1
Takeda
Report the incident to the Medicines and Healthcare Products Regulatory Agency.
View source
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AI-generated summary
Irene Anne Pearson · 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
Irene Anne Pearson had terminal colon cancer that had spread to other organs and was receiving palliative Matrifen patches. On 19 July 2015, she was found dead in a hot bath at home, apparently still wearing the patch; the stated medical cause of death included opiate toxicity. Concerns included warnings about hot baths and patch removal, advice and communication about opiate medication, unclear prescribing records, and the adequacy of information supplied by the GP practice to the Coroner.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to prominently communicate the danger of taking a hot bath whilst wearing the patch
Wider context from the report “1. The package leaflet of advice on the use of Matrifen is very extensive running to several pages of closely printed words. It is not until half way down the eighth page (and then contained in the middle of a 4th bullet point) that there is reference to the danger of taking a hot bath whilst wearing the patch. The Forensic Consultant Toxicologist gave evidence to me that heating of the body will cause an onrush of the delivery of the drug. (Takeda UK)
” Source location Irene Anne Pearson · Prevention of Future Deaths report
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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 Report the incident to the Medicines and Healthcare Products Regulatory Agency.
Verbatim wording from the response “We can confirm that this incident has been reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). For your information, we can additionally confirm that the product information for Fentanyl patches (which include Matrifen) has recently been extensively reviewed by the MHRA to ensure the safety warnings are adequate.” Source location I-Pearson-Response_Redacted
Open published response
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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 current Matrifen leaflet adequately addresses the risk of exposing patches to heat sources.
Verbatim wording from the response “Item 1:
With regard to your specific comment concerning the lack of clarity over heat exposure, we would like to bring your attention the fact that the first page of the Matrifen patient information leaflet displays a list of ‘Important things you need to know about Matrifen transdermal patches’. This comprises 7 bullet points highlighted in bold text, including ‘do not expose the patches to a heat source (such as a hot water bottle)’. Given the need to balance completeness with brevity and understanding in the compilation of patient information leaflets, our current view is that the information presented in the Matrifen leaflet adequately addresses the issue of exposing patches to heat sources.” Source location I-Pearson-Response_Redacted
Open published response
Concerns raised 4
Failure to include required CLP hazard statements View source Failure to use CLP-standard hazard pictograms View source Failure to include the CLP signal word “danger” View source
Failure to provide a tactile warning on the container View source See 1 more concern
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
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AI-generated summary
Stephen Paul Myers · 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
On Christmas Eve 2014, Stephen Paul Myers drank a bottle of isopropyl nitrite (“Poppers”) purchased from a local shop, collapsed, and died after resuscitation was attempted. The concerns included the product’s toxicity if swallowed and the adequacy of its labelling and packaging, including the need for updated hazard information, precautionary statements, pictograms, a signal word and a tactile warning.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to include required CLP hazard statements
Wider context from the report “(1) Isopropyl nitrite is sold as a liquid in a small (25ml) bottle as “English Room Odoriser”. It is known that some inhale the vapour which is thought to cause a short-lived “rush” / euphoria. The label on the bottle says “do not inhale”. It is classified in accordance with 67/548/EEC: R 23: toxic by inhalation R28: very toxic if swallowed.
(2) I have received a report from West Yorkshire Analytical Services which states
“The labelling was examined with respect to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) and the Regulation Classification, Labelling and Packaging of Substances and Mixtures 2008 (CLP) with the following observations:-
Need upgrading for CLP to include the signal word “danger”. Pictograms need updating to CLP standard. Need to include the hazard statements suggested H225 Highly Flammable Liquid and Vapour, H301 Toxic if Swallowed, H331 Toxic if Inhaled. Precautionary statements suggested P210 Keep Away From Heat/Sparks/Open Flames/Hot Surfaces – No smoking, P261 Avoid breathing Vapours, P301 and P310 IF SWALLOWED : Immediately call a POISON CENTRE or Doctor/Physician. The container requires a tactile warning.
” Source location Stephen Paul Myers · Prevention of Future Deaths report
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 use CLP-standard hazard pictograms
Wider context from the report “(1) Isopropyl nitrite is sold as a liquid in a small (25ml) bottle as “English Room Odoriser”. It is known that some inhale the vapour which is thought to cause a short-lived “rush” / euphoria. The label on the bottle says “do not inhale”. It is classified in accordance with 67/548/EEC: R 23: toxic by inhalation R28: very toxic if swallowed.
(2) I have received a report from West Yorkshire Analytical Services which states
“The labelling was examined with respect to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) and the Regulation Classification, Labelling and Packaging of Substances and Mixtures 2008 (CLP) with the following observations:-
Need upgrading for CLP to include the signal word “danger”. Pictograms need updating to CLP standard. Need to include the hazard statements suggested H225 Highly Flammable Liquid and Vapour, H301 Toxic if Swallowed, H331 Toxic if Inhaled. Precautionary statements suggested P210 Keep Away From Heat/Sparks/Open Flames/Hot Surfaces – No smoking, P261 Avoid breathing Vapours, P301 and P310 IF SWALLOWED : Immediately call a POISON CENTRE or Doctor/Physician. The container requires a tactile warning.
” Source location Stephen Paul Myers · Prevention of Future Deaths report
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 include the CLP signal word “danger”
Wider context from the report “(1) Isopropyl nitrite is sold as a liquid in a small (25ml) bottle as “English Room Odoriser”. It is known that some inhale the vapour which is thought to cause a short-lived “rush” / euphoria. The label on the bottle says “do not inhale”. It is classified in accordance with 67/548/EEC: R 23: toxic by inhalation R28: very toxic if swallowed.
(2) I have received a report from West Yorkshire Analytical Services which states
“The labelling was examined with respect to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) and the Regulation Classification, Labelling and Packaging of Substances and Mixtures 2008 (CLP) with the following observations:-
Need upgrading for CLP to include the signal word “danger” . Pictograms need updating to CLP standard. Need to include the hazard statements suggested H225 Highly Flammable Liquid and Vapour, H301 Toxic if Swallowed, H331 Toxic if Inhaled. Precautionary statements suggested P210 Keep Away From Heat/Sparks/Open Flames/Hot Surfaces – No smoking, P261 Avoid breathing Vapours, P301 and P310 IF SWALLOWED : Immediately call a POISON CENTRE or Doctor/Physician. The container requires a tactile warning.
” Source location Stephen Paul Myers · Prevention of Future Deaths report
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 provide a tactile warning on the container
Wider context from the report “(1) Isopropyl nitrite is sold as a liquid in a small (25ml) bottle as “English Room Odoriser”. It is known that some inhale the vapour which is thought to cause a short-lived “rush” / euphoria. The label on the bottle says “do not inhale”. It is classified in accordance with 67/548/EEC: R 23: toxic by inhalation R28: very toxic if swallowed.
(2) I have received a report from West Yorkshire Analytical Services which states
“The labelling was examined with respect to the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) and the Regulation Classification, Labelling and Packaging of Substances and Mixtures 2008 (CLP) with the following observations:-
Need upgrading for CLP to include the signal word “danger”. Pictograms need updating to CLP standard. Need to include the hazard statements suggested H225 Highly Flammable Liquid and Vapour, H301 Toxic if Swallowed, H331 Toxic if Inhaled. Precautionary statements suggested P210 Keep Away From Heat/Sparks/Open Flames/Hot Surfaces – No smoking, P261 Avoid breathing Vapours, P301 and P310 IF SWALLOWED : Immediately call a POISON CENTRE or Doctor/Physician. The container requires a tactile warning.
” Source location Stephen Paul Myers · Prevention of Future Deaths report
Open source report
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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 Send the coroner’s report and recommendations to Darlington Trading Standards for investigation of the product’s labelling.
Verbatim wording from the response “The appropriate body with the power to enforce the requirements of CHIP/CLP in the case of the labelling and other requirements of these products is the local Trading Standards Authority, in this case, Darlington. The local authority Trading Standards Service will investigate whether the product was mis-labelled in accordance with CHIP/CLP legislation and decide on an appropriate course of action. We are sending them a copy of your report and recommendations.” Source location 2015-0150-Response-by-Department-for-Business-Innovation-Skills
Open published response
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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 CHIP/CLP labelling of poppers lies with the Health and Safety Executive, not this Department.
Verbatim wording from the response “You have suggested that action could be taken by this Department in order to ensure clear labelling of products like poppers in an attempt to avoid repetitions of this tragic accident. I should clarify that BIS is not responsible for the CHIP/CLP legislation regarding the labelling of bottles of Poppers (isopropyl nitrite). This is the policy of the Health and Safety Executive. The CLP labelling on this product would depend on the concentration of isopropyl nitrite and the nature and concentration of other ingredients, and follows prescribed ‘rules’ set under EU single market legislation. Whether or not certain label statements such as ‘If swallowed: Immediately call a Poison Centre or doctor/physician’ are used depends on the classification of the product, which is based on scientific data.” Source location 2015-0150-Response-by-Department-for-Business-Innovation-Skills
Open published response
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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 Darlington Trading Standards is responsible for investigating compliance with CHIP/CLP labelling requirements and deciding enforcement action.
Verbatim wording from the response “The appropriate body with the power to enforce the requirements of CHIP/CLP in the case of the labelling and other requirements of these products is the local Trading Standards Authority, in this case, Darlington. The local authority Trading Standards Service will investigate whether the product was mis-labelled in accordance with CHIP/CLP legislation and decide on an appropriate course of action. We are sending them a copy of your report and recommendations.” Source location 2015-0150-Response-by-Department-for-Business-Innovation-Skills
Open published response
12 Nov 2014 Patricia Ann Mellor · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 2
Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS View source Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Patricia Ann Mellor · 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
Patricia Ann Mellor suffered a cardiac arrest during general anaesthesia in 2004, resulting in a hypoxic brain injury and severe disability. She died from aspiration pneumonia on 24 January 2014. The investigation identified acquired Long QT Syndrome associated with a combination of citalopram, nortriptyline and ranitidine, and concerns were raised about the need to identify and manage this risk before anaesthesia.
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 include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Source location Patricia Ann Mellor · Prevention of Future Deaths report
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 include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Source location Patricia Ann Mellor · Prevention of Future Deaths report
Open source report
29 Sep 2014 Tiya Chetan Chauhan · Prevention of Future Deaths report Inner West London
View report summary
Concerns raised 1
Absence of choking-risk warnings on packets of raw jelly View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
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AI-generated summary
Tiya Chetan Chauhan · 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
Tiya Chetan Chauhan died on 24 August 2012 at St George’s Hospital after inhaling a cube of raw jelly that obstructed her airway during a sensory tray activity at a nursery. The report identified concerns about the choking risk of raw jelly cubes, inadequate supervision, insufficient risk assessment, and the absence of warnings on packets of raw jelly.
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× 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 packets of raw jelly
Wider context from the report “(2) That packets of raw jelly do not contain a warning that cubes of jelly present a choking risk to children .
” Source location Tiya Chetan Chauhan · Prevention of Future Deaths report
Open source report
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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 Forward the report to relevant food manufacturing and retail trade bodies for information and consideration regarding warnings about raw jelly cube risks.
Verbatim wording from the response “In relation to your concerns over the lack of warning about the issue on packaging, the FSA will forward a copy of your report to relevant industry manufacturing and retail trade bodies, for their information and consideration. I can confirm that there is no specific legal requirement (in what is an area of law closely harmonised at EU level) for such food to contain a warning on the label or on a point of sale notice if sold loose. However, this is something that a particular manufacturer or retailer” Source location 2014-0575-Response-by-Food-Standards-Agency
Open published response
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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 Warnings on food-product packaging are outside Ofsted’s remit.
Verbatim wording from the response “The inclusion of warnings on the packaging of food items and products is not a matter for Ofsted. We have discussed this concern with the FSA and have agreed that they will respond to you on the possibility for further action.” Source location 2014-0575-Response-by-Ofsted
Open published response
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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 Food Standards Agency will respond about possible further action on warnings for raw jelly packaging.
Verbatim wording from the response “The inclusion of warnings on the packaging of food items and products is not a matter for Ofsted. We have discussed this concern with the FSA and have agreed that they will respond to you on the possibility for further action.” Source location 2014-0575-Response-by-Ofsted
Open published response
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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 specific legal requirement to require warnings on packaging or loose-food point-of-sale notices; manufacturers and retailers may act voluntarily.
Verbatim wording from the response “In relation to your concerns over the lack of warning about the issue on packaging, the FSA will forward a copy of your report to relevant industry manufacturing and retail trade bodies, for their information and consideration. I can confirm that there is no specific legal requirement (in what is an area of law closely harmonised at EU level) for such food to contain a warning on the label or on a point of sale notice if sold loose. However, this is something that a particular manufacturer or retailer” Source location 2014-0575-Response-by-Food-Standards-Agency
Open published response
16 Oct 2013 JOHN JAMES JACKSON · Prevention of Future Deaths report Black Country
View report summary
Concerns raised 1
Danger of treating caffeine-containing energy mints as ordinary sweets View source
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
JOHN JAMES JACKSON · 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
JOHN JAMES JACKSON was found dead at his home, and life was pronounced extinct at 12 noon on 2 May 2013. Evidence indicated that he was a compulsive user of Hero Energy Mints and had more than twice the blood caffeine level reported as capable of producing a fatality. The concerns included limited information about the product’s caffeine content and the dangers of consuming large quantities, and its position between medication and sweets.
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 Danger of treating caffeine-containing energy mints as ordinary sweets
Wider context from the report “I heard and accepted evidence that the deceased was a compulsive user of a product called “Hero Energy Mints”. This produce is advertised as having “More than all the normal advantages of energy drinks in an easy to use format”. The advertising says that one mint equals one whole energy drink. It went onto say that the product contains caffeine. However, the information available on the internet at the time of the inquest contained no information at all as to the dangers of consuming large quantities of the mints. At the inquest, the evidence from the pathologist showed that Mr. Jackson had in his blood at the time of death, more than twice the level of caffeine that can produce a fatality and around 50 times the level that would be found normally in someone drinking tea and coffee.
a) There was at the time little information available as to the level of caffeine in this product and the dangers of consuming large amounts of caffeine,
b) The product seems to me to sit uncomfortably in a gap between medication and sweets , when any person treating the product simply as sweets maybe in danger . I acknowledge of course, that part of the answer is public awareness and I trust that the publicity that was given to this case may assist in that regard.
” Source location JOHN JAMES JACKSON · Prevention of Future Deaths report
Open source report
Actions and positions describe what organisations say in published responses. Implementation is not independently verified.