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Urgent Field Safety Notice/ Physician AdvisoryCOMMERCIAL NAME: Absorb and Absorb GT1 Bioresorbable Vascular Scaffold (BVS)
Systems
Date: March 31, 2017,
Type of Action: Advice regarding the use of
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Gather all necessary information including product details, nature of the safety issue, and any relevant reports or data.
02
Clearly outline the steps needed to address the safety issue and prevent any potential harm to users.
03
Provide contact information for any inquiries or further assistance.
04
Distribute the filled out urgent field safety notice to the appropriate stakeholders and regulatory bodies.
Who needs urgent field safety notice?
01
Manufacturers of products that pose a safety risk to consumers or users.
02
Distributors or retailers who may need to recall or stop sales of the affected products.
03
Regulatory bodies who oversee product safety standards and compliance.
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What is urgent field safety notice?
An urgent field safety notice is a communication from a manufacturer to inform users about potential risks associated with a medical device, suggesting necessary actions to mitigate those risks.
Who is required to file urgent field safety notice?
Manufacturers or authorized representatives 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, include details of the device, description of the issue, risk assessment, actions required from users, and contact information for further inquiries.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to ensure that users are informed about safety issues related to a medical device and to provide guidance on actions to protect patient safety.
What information must be reported on urgent field safety notice?
The information that must be reported includes device identification, nature of the safety issue, risk levels, corrective actions, and the timeline for those actions.
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