PFD report

Nadine Brookes-Walker · Prevention of Future Deaths report

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Issued 16 Nov 2015•Manchester North

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.

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Concerns
1

Raised in this report

Recipients
2

Named on the report

Responses found
1

Of 2 recipients

Stated actions
1

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

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Report evidence summary

Concerns raised1

  1. Inadequate packaging warnings about the consequences of using damaged Fentanyl patches
    Part of recurring concern: Inadequate safety warnings on medication packaging
Responses linked to these concerns

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

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The current Matrifen leaflet adequately addresses the risk of damaged patches.

    Stated by Takeda UK LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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

Inadequate packaging warnings about the consequences of using damaged Fentanyl patches

Wider context from the report

“Warning regarding the seriousness of the consequences of using damaged Fentanyl patches may not be apparent to the patient from the packaging ”

Is this part of a recurring concern?

Yes — Inadequate safety warnings on medication packaging.

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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 damaged patches.

Verbatim wording from the response

“Matters of concern: With regard to your specific comment ‘warning regarding the seriousness of the consequences of using damaged fentanyl patches may not be apparent to the patient from the packaging’ and your request for ‘action to be taken to prevent future deaths’ we would like to bring to your attention section 3 of the Matrifen patient information leaflet (PIL) where the following is mentioned:”

Source location

Nadine-Brooks-Response
Page 1 · response
Published 16 November 2015

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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 brand leader manufacturer was asked to review whether product information changes were required.

Verbatim wording from the response

“Furthermore, as we are required to ensure that the PIL for Matrifen is consistent with that of the brand leader product Durogesic, marketed by Johnson & Johnson, we have requested that they conduct a review to determine whether any changes are required to the product information as a result of this incident. I understand that this is still under investigation.”

Source location

Nadine-Brooks-Response
Page 1 · response
Published 16 November 2015

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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

    Report the incident to the MHRA through the Yellow Card scheme.

    Stated by Takeda UK LimitedStated completedThe respondent said that this action was complete when they made their response on 16 November 2015.

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 MHRA through the Yellow Card scheme.

Verbatim wording from the response

“Lastly, we can confirm that this incident has been reported to the MHRA via the yellow card scheme.”

Source location

Nadine-Brooks-Response
Page 1 · response
Published 16 November 2015

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