(Insert Company Name)
Field Safety Notice for (Insert Product Name and Version Number)
(Date)
Please note: This Field Safety Notice (FSN) must be presented in the official language(s) of the country where the device is being used. Translation may be necessary.
For reference, the German BfArM provides [past reports as examples][bfarm-past-reports] that manufacturers can use as templates.
(Page 1: Cover Letter)
Dear Valued Customer,
At (Company Name), we prioritize the ongoing safety and reliability of our products through continuous and rigorous monitoring.
During the course of our product surveillance activities, we have identified a potential issue that may affect the device’s performance.
We are providing the following details to ensure you are fully informed:
- A description of the issue and the conditions under which it may occur.
- Recommended measures to mitigate or prevent the problem.
- Planned actions by (Company Name) to address and resolve the issue.
Should you require any further assistance or clarification, please contact our representative: (Insert Company Contact Details and Name of Responsible Person).
We sincerely apologize for any inconvenience caused.
Best regards,
(Insert Name of Medical Device Safety Officer or Regulatory Compliance Representative)
(Page 2: FSN Report)
(Product Name)
Field Safety Notice for (Version Number)
(Date)
This document contains critical information for the safe and proper use of your medical device.
Please ensure that all relevant staff review and understand the content of this notice. Keep a copy with the device’s Instructions for Use, and confirm receipt of this communication.
| Affected Product: | |
| Unique Device Identification: | |
| Version: | |
| Problem Description: | |
| Associated Risk: | |
| Recommended Actions: | |
| Planned Actions by (Company Name): | |
| Further Information and Support: | (Include contact details for regional or national assistance.) |