Freedom of Information request on access to the reported adverse events (if any) for the following medical devices: Puraplas ;Dermal Roller; Cannulas; PDO Threads (FOI 22/522)
Published 1 June 2022
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FOI 22/522
31st March 2022
Dear
Thank you for your information request, dated 8 March 2022.
You asked for:
“Please also kindly help me to have access to the reported adverse events (if any) for the following medical devices:
1.Puraplas
- Dermal Roller
3.Cannulas
- PDO Threads”
Response to your enquiry can be found in the table below which shows the number of reports for adverse events submitted in relation to the following as of 10th March 2022 inclusive.
The table includes reports received from manufacturers, healthcare professionals and members of the public.
These figures need to be interpreted with caution as they are not the same as complication rates.
| Product | Number of incidents on the MHRA database |
|---|---|
| 1.Puraplas | None reported. |
| 2. Dermal Roller (and its variations ‘derma roller’ and ‘dermaroller’) | Less than 5 incidents reported. |
| 3.Cannulas | We cannot provide the data due to the request being insufficiently specific. If you wish to submit a more specific request about cannula devices then we can focus our search to produce meaningful results. |
| 4. PDO Threads | Less than 5 incidents reported. |
It is important to note that the inclusion of a report on our adverse incident database does not necessarily mean the events described were caused by that device but could be due to unrelated patient/user factors.
The data must be read together with the following explanations:
• The majority of reports indicate an issue experienced by a single user. However, some cases may represent the same user experiencing further issues or multiple events in the same report.
• Reports do not necessarily represent an individual patient. Individuals may report an incident at any time after the event and people can make multiple reports at any time after the use of device and on the same issue. Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always be sure enough to link every duplicate
• It should be noted that this information may include a range of recognised complications related to this type of procedure and does not necessarily indicate a fault with any particular device.
• The numbers may include reports where the incident has been taken from published literature or the report may be about notification of a safety communication.
• These numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.
As with all medical devices MHRA continues to monitor the safety and performance and encourages reporting of any adverse incidents through its Yellow Card scheme on https://yellowcard.mhra.gov.uk/.
If you have a query about the information provided, please reply to this email
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: [email protected]
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
I hope this answers your enquiry.
Yours sincerely
MHRA Customer Experience Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000