Get the free URGENT FIELD SAFETY NOTICE - EXTENSION
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Telefax Medical GmbH
WillyRschStr. 4 10
71394 Kernel
Germany
27 Feb 2014URGENT
FIELD SAFETY NOTICE EXTENSION
COMMERCIAL NAME OF
AFFECTED PRODUCTS:
LintonNachlas Tube
Sengstaken Tube
Pediatric Sengstaken
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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 pertaining to the safety issue
02
Identify all affected products and serial numbers
03
Draft a detailed description of the safety concern and potential hazards
04
Include instructions for users on how to mitigate the risk
05
Fill out the urgent field safety notice form accurately and completely
06
Submit the form to the appropriate regulatory authorities and stakeholders
Who needs urgent field safety notice?
01
Manufacturers
02
Distributors
03
Retailers
04
Healthcare facilities
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by manufacturers or distributors to alert healthcare professionals, patients, or users about safety issues related to a medical device or product that requires immediate attention.
Who is required to file urgent field safety notice?
Manufacturers of medical devices or health-related products are required to file an urgent field safety notice when a safety or health risk has been identified.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, manufacturers should provide clear information regarding the issue, instructions for action to be taken, details of the product impacted, and the timeframe for implementing corrective measures.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to inform and protect users by facilitating timely action to prevent adverse events related to the identified safety concerns.
What information must be reported on urgent field safety notice?
The notice must include details such as the product identification, nature of the safety issue, potential risks, instructions for users, and contact information for further inquiries.
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