PFD report

Susan Marion LAKIN · Prevention of Future Deaths report

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Issued 11 Apr 2025•Rutland and North Leicestershire

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
3

Raised in this report

Recipients
2

Named on the report

Responses found
3

Of 2 recipients

Stated actions
11

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised3

  1. Failure to provide purchasers with warnings about the risks of high-risk lap belts
    Part of recurring concern: Failure to provide safety warnings at point of sale for hazardous products and equipment
  2. Unrestricted online availability of high-risk healthcare equipment to untrained purchasers
  3. Failure to provide guidance on professional supervision or fitting of lap belts
    Part of recurring concern: Failure to ensure clear and followed instructions for safe equipment use
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.10

  1. Action

    Highlight activity concerning support-belt safety to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.

    Stated by Office for Product Safety and StandardsStated completedThe respondent said that this action was complete when they made their response on 17 April 2025.
  2. Action

    Continue monitoring evidence and engaging UK retailers and manufacturers to promote clear instructions and warnings and safer foreseeable use.

    Stated by Office for Product Safety and StandardsStated in progressThe respondent said that this action was in progress when they made their response on 17 April 2025.
  3. Action

    Review wider intelligence on wheelchair and armchair support belts, including incidents, standards and product instructions and warnings.

    Stated by Office for Product Safety and StandardsStated completedThe respondent said that this action was complete when they made their response on 17 April 2025.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    Responsibility for concerns about lap belt product advertising, sale, warnings and safety information sits with another organisation.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to provide purchasers with warnings about the risks of high-risk lap belts

Wider context from the report

“The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”. The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional. The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation. It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same. ”

Is this part of a recurring concern?

Yes — Failure to provide safety warnings at point of sale for hazardous products and equipment.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Unrestricted online availability of high-risk healthcare equipment to untrained purchasers

Wider context from the report

“The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”. The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional. The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation. It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to provide guidance on professional supervision or fitting of lap belts

Wider context from the report

“The advertisement and sales particulars for the lap belt that they purchased states “fits any armchair”, that it provides “extra support to prevent accidents” and finally that it provides “adequate trunk stability avoiding lateral displacements and slides” and “minimises the chance that the patient will... suffer any injuries, tilting or slipping”. The advertisement and sales particulars contain no warning about the risks that are associated with the use of the lap belt, nor any suggestion that the lap belt should be used or fitted under the guidance/supervision of a therapist or medical professional. The evidence heard at the inquest was that the lap belt should be considered a “high risk” piece of equipment (it is categorised as such in the local NHS Trust’s Standard Operating Procedure) and that appropriate warnings should be given to those purchasing lap belts in relation to the risks of physical restraint, tissue viability risks and finally the risk of strangulation. It is concerning that people who have no healthcare training at all can purchase high risk equipment for their loved ones online without being appraised of those risks or even being informed about the high risk nature of the equipment. Lap belts, and other seemingly basic pieces of healthcare equipment, are readily available for people to purchase online without them being appraised of the risks that come with the use of the same. ”

Is this part of a recurring concern?

Yes — Failure to ensure clear and followed instructions for safe equipment use.

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 activity concerning support-belt safety to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.

Verbatim wording from the response

“On this basis, OPSS is taking further action on this product category. We have written to major online marketplaces, including Amazon, eBay, Temu, Shein and Alibaba, to make them aware that certain products may not be provided with suitable instructions or warnings to assure safe use by likely users. This will assist online marketplaces to identify whether these products are available on their platforms and take action to update or remove relevant listings. OPSS has also alerted online marketplaces to our Product Safety Report published for the ORTONES belt to make clear this product should not be supplied. OPSS has highlighted our activity for these products to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.”

Source location

Response from Office for Product Safety and Standards
Page 2 · response
Published 17 April 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

Continue monitoring evidence and engaging UK retailers and manufacturers to promote clear instructions and warnings and safer foreseeable use.

Verbatim wording from the response

“OPSS is continuing to monitor the available evidence and engage with retailers and manufacturers in the UK, to ensure products are supplied with clear and appropriate instructions and warnings and do not pose a risk when they are used normally and foreseeably.”

Source location

Response from Office for Product Safety and Standards
Page 2 · response
Published 17 April 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

Review wider intelligence on wheelchair and armchair support belts, including incidents, standards and product instructions and warnings.

Verbatim wording from the response

“Alongside the steps to reduce the risk to consumers posed by the ORTONES belt, OPSS has been gathering wider intelligence into wheelchair/armchair support belt products. There is a broad range of similar support belts and harnesses available to UK consumers, supplied via online marketplaces and by specialist retailers. This review did not find any evidence of product safety concerns raised by Trading Standards or Citizens Advice, and OPSS had not received notifications about support belts to our Product Safety Database from other regulators.”

Source location

Response from Office for Product Safety and Standards
Page 2 · response
Published 17 April 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

Write to major online marketplaces about inadequate instructions and warnings, and alert them that the ORTONES belt should not be supplied.

Verbatim wording from the response

“On this basis, OPSS is taking further action on this product category. We have written to major online marketplaces, including Amazon, eBay, Temu, Shein and Alibaba, to make them aware that certain products may not be provided with suitable instructions or warnings to assure safe use by likely users. This will assist online marketplaces to identify whether these products are available on their platforms and take action to update or remove relevant listings. OPSS has also alerted online marketplaces to our Product Safety Report published for the ORTONES belt to make clear this product should not be supplied. OPSS has highlighted our activity for these products to relevant stakeholders, including Age UK and the Royal Society for the Prevention of Accidents.”

Source location

Response from Office for Product Safety and Standards
Page 2 · response
Published 17 April 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

Publish a product safety report warning about the ORTONES belt and documenting the corrective action taken.

Verbatim wording from the response

“These steps should ensure the product is no longer available to purchase in the UK. On 31 October, OPSS published a product safety report for the ORTONES belt on the Product”

Source location

Response from Office for Product Safety and Standards
Page 1 · response
Published 17 April 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

Write to the Office of Product Safety and Standards expressing concerns about the lap belt product.

Verbatim wording from the response

“I will be writing to the Office of Product Safety and Standards with my deep concerns about the product in question. You may also like to make the OPSS aware of your concerns.”

Source location

Response from DHSC
Page 1 · response
Published 17 April 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

Advise OPSS of concerns about support belts and highlight the missing safety information in the ORTONES belt instructions.

Verbatim wording from the response

“Given this, the MHRA has advised the relevant regulator, the Office of Product Safety and Standards (OPSS), to ensure that they are aware of your concerns.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 4 · response
Published 17 April 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

Review the relevant safety standard and ORTONES belt instructions for warnings concerning prescription, fitting, skin injury and strangulation risks.

Verbatim wording from the response

“Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 4 · response
Published 17 April 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

Inform OPSS about the ongoing investigation and include it in manufacturer communications to assess proposed corrective actions.

Verbatim wording from the response

“Eurobaston S.L. has committed to the re-evaluation of the ORTONES belt design, labelling and instructions for use. Eurobaston S.L. have informed us that they will be working with Comercial Nespral S.L to determine what corrective actions can be implemented for ORTONES belts that have been distributed in the UK. The MHRA will inform OPSS of this ongoing investigation into the sale of support belts without the appropriate warnings, including the ORTONES belt. In addition, we will include OPSS in our communications with the Eurobaston S.L, to assess the appropriateness of their corrective actions.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 6 · response
Published 17 April 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

Refer wheelchair belts meeting medical-device or accessory definitions but lacking MHRA registration to the compliance team.

Verbatim wording from the response

“Any wheelchair belts which would fall under the definition of a medical device or accessory and are not registered with the MHRA will be referred to the MHRA’s compliance team.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 6 · response
Published 17 April 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

Responsibility for concerns about lap belt product advertising, sale, warnings and safety information sits with another organisation.

Verbatim wording from the response

“The report raises concerns over the advertisement and sale of the lap belt products which led to Mrs Lakin’s death, and the lack of warning and information around the dangers that could arise from their use. Officials within the Department of Health and Social Care have considered these concerns and concluded that the responsibility for these concerns sits within another organisation. I understand the Medicines and Healthcare products Regulatory Agency (MHRA) is also responding to your report, and I hope that their response will be helpful.”

Source location

Response from DHSC
Page 1 · response
Published 17 April 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

The Office of Product Safety and Standards is the relevant regulator for concerns about unregulated supportive belts and their warnings.

Verbatim wording from the response

“In addition to the concerns regarding the ORTONES belt, we have identified several other supportive belts that are sold online that do not appear to be registered with the MHRA. However, they also make general claims, similar to the ORTONES belt, and are therefore unlikely to qualify as medical devices or accessories to a medical device.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 4 · response
Published 17 April 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

Support belts marketed for general accident prevention are generally unlikely to qualify as medical devices or accessories under UK regulations.

Verbatim wording from the response

“The MHRA’s Borderline team have reviewed the intended use and claims of the ORTONES belt and concluded that wheelchair belts are unlikely to meet the definition of a medical device in their own right, as the intended purpose is to prevent accidents and falls, which is not considered to be a medical purpose.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 3 · response
Published 17 April 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

Addressing missing warnings for belts not classified as medical devices or accessories is outside the regulator’s remit.

Verbatim wording from the response

“Warnings. We have reviewed the ISO standard for Selection, placement and fixation of flexible postural support devices in seating (part 15 of the wheelchair seating series): ISO/TS 16840-15:2024. The purpose of this standard is to specify the criteria to be applied to positioning supports when used in seating systems and chairs.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 4 · response
Published 17 April 2025

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. 1

    Continue monitoring adverse incident reports and take necessary action in response to reported concerns.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 17 April 2025.

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 monitoring adverse incident reports and take necessary action in response to reported concerns.

Verbatim wording from the response

“Pending the conclusion of the investigation and actions detailed above, we will continue to monitor all adverse incidence reports we receive and take any necessary action as appropriate.”

Source location

Response from The Medicine and Healthcare Products and Regulatory Agency
Page 6 · response
Published 17 April 2025

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026