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Urgent Field Safety Noticeboard Reflux Testing System Instructions for Use Outline Important Procedural Steps for Capsule Placement Customer Notification April 2021 Medtronic Reference: FA956 Dear
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Identify the urgent field safety notice form or template that needs to be filled out.
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Collect all relevant information regarding the safety concern or issue that requires urgent attention.
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What is urgent field safety notice?
Urgent field safety notice is a communication sent out to inform users of a medical device about a potential safety issue.
Who is required to file urgent field safety notice?
Manufacturers, importers, and distributors of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, one must provide detailed information about the safety issue, affected product, recommended actions, and contact information.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notices is to alert users of medical devices about potential safety issues and to provide guidance on mitigating risks.
What information must be reported on urgent field safety notice?
Information such as the description of the safety issue, affected product details, recommended actions, and contact information must be reported on urgent field safety notices.
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