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Updated July 27, 2021

Template: Field Safety Notice

Sven Piechottka
ISO 13485

This is a free template, provided by OpenRegulatory.

A preview of the template is shown below. You can download it as Word (.docx), PDF or markdown file.

The template license applies (don't remove the copyright at the bottom).

Download as:

Related Documents

The following templates are Documents or SOPs related to this template. That means that they mention this template somewhere and (most likely) contain instructions on how and when to fill it out.
Beginning of template

(Enter Company Name)

Field Safety Notice for (Enter Product Name and Version Number)

(Enter Date)

Keep in mind that FSN has to be written in the language of the country you are operating your device in, so you may have to translate this template text.

For your orientation: the German BfArM has also published past reports as templates to be used by other manufacturers.

(Page 1: Cover Letter)

Dear Customer,

Our company’s products are subject to continuous and rigorous surveillance to ensure ongoing safety and reliability while being used.

As part of our product surveillance, we identified a potential problem that could impact the performance of the device.

We would therefore like to provide you with the following information:

If you need any further information or support concerning this, please reach out to our company representative: (Company Contact Details and Responsible Person)

We would like to apologize for any inconveniences.

Sincerely,

(Enter name of responsible Medical Device Safety Officer / Person Responsible for Regulatory Compliance)


(Page 2: FSN Report)

(Product Name)

Field Safety Notice for (Version Number)

(Date)

This document contains important information for the continued safe and proper use of your medical device.

Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy with the Instructions for Use and confirm the receipt of this notice.

   
Affected Product:  
Unique Device Identification:  
Version:  
Problem Description:  
Hazard Involved:  
Recommended Actions:  
Actions Planned by (company name):  
Further Information and Support: (Refer to a country contact including information on availability.)

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

End of template

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