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008729603/12/2021DGDMFMDSA Allegato Utente 1 (A01)URGENT FIELD SAFETY NOTICE MAGEC DEVICE SYSTEMDate:December 1, 2021Commercial Name:MAGEC Device SystemType of Action:Advisory NoticeNuVasive Specialized
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How to fill out urgent field safety notice
How to fill out urgent field safety notice
01
Start by gathering all relevant information regarding the safety issue.
02
Clearly describe the safety concern and its potential impact on users.
03
Provide detailed instructions on how to mitigate the safety issue.
04
Include any testing or verification steps that need to be taken.
05
Clearly outline deadlines and contact information for any questions or concerns.
Who needs urgent field safety notice?
01
Manufacturers of medical devices
02
Distributors of medical devices
03
Healthcare facilities and professionals
04
Regulatory authorities
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What is urgent field safety notice?
Urgent field safety notice is a notification that must be submitted to regulatory authorities when a medical device poses a serious risk to the health and safety of patients.
Who is required to file urgent field safety notice?
Manufacturers, authorized representatives, and distributors of medical devices are required to file urgent field safety notices.
How to fill out urgent field safety notice?
Urgent field safety notices should include detailed information about the medical device, the identified safety issue, actions taken or recommended, and contact information for further communication.
What is the purpose of urgent field safety notice?
The purpose of urgent field safety notices is to inform regulatory authorities, healthcare professionals, and patients about potential risks associated with a medical device and to ensure timely actions are taken to mitigate these risks.
What information must be reported on urgent field safety notice?
Information such as device description, risk assessment, affected lots or serial numbers, distribution details, and corrective actions must be reported on urgent field safety notices.
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