Get the free Field Safety Notice - Aadva Twist Drill
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This safety notice informs customers about a potential diameter issue with Aadva Twist Drill included in Surgical Kit S, requiring product return for safety.
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What is field safety notice?
A field safety notice (FSN) is a communication issued by a manufacturer or an authorized representative to inform users, customers, and other stakeholders about potential safety issues related to a medical device or product.
Who is required to file field safety notice?
Manufacturers and their authorized representatives are required to file field safety notices when they identify potential safety risks associated with their products.
How to fill out field safety notice?
To fill out a field safety notice, you should follow a specific template that includes details about the product, description of the safety issue, actions to be taken, and the timeline for addressing the issue.
What is the purpose of field safety notice?
The purpose of a field safety notice is to proactively communicate safety concerns to prevent harm, ensure customer awareness, and facilitate necessary actions to address the safety issue.
What information must be reported on field safety notice?
A field safety notice must report the product identification, details of the safety issue, risks associated with the issue, recommended actions for users, and contact information for further inquiries.
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