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FIELD SAFETY NOTICE Intertribal Shunt Device (ASD) System II
Cor via Medical FSCA0220200928
Change to the Instructions for Use:
IFU Part Number 00453AW Rev 06 Advice given by manufacturer regarding
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Identify the urgent field safety notice form provided by the relevant authority or organization
02
Fill out the contact information section with your details
03
Provide a detailed description of the safety issue or incident that requires urgent attention
04
Include any relevant supporting documentation or evidence
05
Submit the filled out form by the specified deadline
Who needs urgent field safety notice?
01
Any individual or organization that has identified a safety issue or incident that poses an immediate risk and requires urgent action to address
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by manufacturers or regulatory authorities to inform users and healthcare professionals about a safety issue related to a medical device that poses a risk to patients' health.
Who is required to file urgent field safety notice?
Manufacturers of medical devices are required to file an urgent field safety notice when they identify a safety issue that affects their product and may pose a risk to patients.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, manufacturers should include information about the product, the nature of the safety issue, actions to be taken by users, and reporting procedures.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to ensure timely communication of safety issues to prevent harm to patients and to facilitate corrective actions in a structured manner.
What information must be reported on urgent field safety notice?
The information that must be reported includes the product details, the specific safety issue, affected lots or serial numbers, actions to be taken, and contact details of the manufacturer.
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