Freedom of Information request on information on yellow cards for Histoacryl Glue rather than brand specific (FOI 21/1132)
Published 26 May 2022
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FOI 21/1132
4th November 2021
Dear,
Thank you for your information request, dated 13/10/2021, where you asked “Would you be able to release the information on yellow cards for Histoacryl Glue rather than brand specific?”.
I am pleased to provide you with the information requested, see below.
A total of five incidents involving all surgical tissue adhesives have been reported, between 1/12/2020 and 20/10/2021, through the Yellow Card scheme. Please note that the five reported incidents include all brands and devices that fit under the surgical tissue adhesives category. When considering this data, it is important to be aware of the following points:
- These numbers are accurate at the time of extraction from our database, on 20/10/2021. Changes in the numbers can occur if new information is submitted at a later date, for example.
- A report of an adverse incident involving a medical device does not mean that the medical device caused the incident.
- These figures need to be interpreted with caution. Consideration must be given to the individual procedures being undertaken, the skill of the healthcare professional performing the procedure, and the individual patient conditions.
- The information we hold on our database is not a complete picture of all the device-related incidents that happen in healthcare, it is just a snapshot.
- Therefore, our data must not be used to make a judgement on the safety of a particular type of medical device or how likely it is to be involved in an adverse incident or an estimate of complication rates.
- The use of the Yellow Card scheme by members of the public and the healthcare sector is voluntary but we strongly encourage it.
- Reports do not necessarily represent an individual patient. Multiple reports on the same issue might be submitted. Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always guarantee that every duplicate is linked.
- All reports received via Yellow Card are sent to the relevant manufacturer (if known and anonymised as appropriate) to feed into the vigilance system to monitor the safety of medical devices and to act on safety signals.
The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000