PFD report

Philip Lesnes · Prevention of Future Deaths report

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Issued 27 Feb 2025•Dorset

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
4

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
3

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 raised4

  1. Choking hazard from adhesive gel products
  2. Failure to include adhesive gel products in care home risk assessments
  3. Exposure of older and cognitively impaired users to adhesive gel products
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.2

  1. Action

    Feature the incident and generic denture-adhesive risks on the Learning from safety incidents webpage, including provider risk-assessment and care-planning guidance.

    Stated by Care Quality CommissionStated plannedThe respondent said that this action was planned when they made their response on 27 February 2025.
  2. Action

    Assess ingredient and finished-product safety throughout product development and after market introduction.

    Stated by FixodentStated completedThe respondent said that this action was complete when they made their response on 27 February 2025.

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

  1. Position

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

    Stated by Care Quality CommissionOutside remitThe respondent said that this matter was outside its role or authority.

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

Choking hazard from adhesive gel products

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. ”

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 include adhesive gel products in care home risk assessments

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. ”

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

Exposure of older and cognitively impaired users to adhesive gel products

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. ”

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

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. ”

Is this part of a recurring concern?

Yes — Inadequate product safety warnings about serious hazards.

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

Feature the incident and generic denture-adhesive risks on the Learning from safety incidents webpage, including provider risk-assessment and care-planning guidance.

Verbatim wording from the response

“In terms of action that will be taken by CQC, it is recommended that this incident should be featured as an issue on CQC’s Learning from safety incidents webpage. This would help raise awareness and share the learning with providers to help prevent similar incidents in the future. This webpage should reference:”

Source location

Response from CQC
Page 1 · response
Published 27 February 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

Assess ingredient and finished-product safety throughout product development and after market introduction.

Verbatim wording from the response

“Our commitment to safety is unwavering. We rigorously assess the safety of all our ingredients and finished products before they are introduced, employing well-established risk assessment methods to evaluate potential hazards including choking and potential exposures. These evaluations are integral to our product development process starting from the early design stages and continuing after the products are made available on the market. Ensuring the safety of our products, packaging, and operations for our employees, consumers and the environment is a fundamental aspect of conducting responsible business and is crucial for building and maintaining public trust.”

Source location

Response from Procter and Gamble UK
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

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

The product does not pose a choking risk when used as intended, and the incident involved use contrary to instructions.

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

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

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

    Monitor adverse events through the established post-market surveillance system, continuing routine monitoring of the product.

    Stated by FixodentStated completedThe respondent said that this action was complete when they made their response on 27 February 2025.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    The death was not avoidable harm resulting from a registered provider failure.

    Stated by Care Quality CommissionDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 adverse events through the established post-market surveillance system, continuing routine monitoring of the product.

Verbatim wording from the response

“Our commitment to consumer safety is evident in our comprehensive post-market surveillance system which monitors any adverse events related to our products. This proactive approach aims to prevent future incidents and enhance overall consumer safety. The data from our surveillance system confirms that the product is safe with clear usage instructions.”

Source location

Response from Procter and Gamble UK
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

The death was not avoidable harm resulting from a registered provider failure.

Verbatim wording from the response

“In summary, we found Mr Jones’ death was not the result of avoidable harm resulting from a registered person/provider failure.”

Source location

Response from CQC
Page 1 · response
Published 27 February 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
2/2

Data last updated 7 September 2026