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Announcement: Withdrawal of products indicated for transvaginal placement of pelvic organ prolapse produced by Boston Scientific Corporation. 6 May 2019 Affected products Perform Soft Tissue Repair
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How to fill out urgent field safety notice

How to fill out urgent field safety notice
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Gather all necessary information related to the safety notice
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Fill out the required fields such as product identification, safety issue, action required, etc.
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Who needs urgent field safety notice?
01
Any organization or individual responsible for the safety of a product or service that has been identified with a safety issue
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What is urgent field safety notice?
Urgent field safety notice is a communication sent out by a manufacturer or distributor to inform users of a medical device about a potential safety issue that requires immediate attention.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and authorized representatives of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices should be filled out with detailed information about the safety issue, affected product, potential risks, recommended actions, and contact details for further assistance.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notice is to alert users of a medical device about potential safety risks and provide guidance on what actions should be taken to mitigate those risks.
What information must be reported on urgent field safety notice?
Information such as the description of the safety issue, affected product details, potential risks to users, recommended actions, and contact information for further assistance must be reported on urgent field safety notice.
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