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URGENT FIELD SAFETY NOTICE Precise ILL Date:October 14, 2021Commercial Name: Precise Intramedullary limb lengthening (ILL) device system, including the Precise ILL and Precise Short trade names Type
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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 necessary information regarding the safety issue.
02
Clearly describe the problem and potential hazards in the notice.
03
Include detailed instructions on how to address the safety issue.
04
Specify any affected products or equipment.
05
Provide contact information for reporting incidents or seeking further clarification.
06
Distribute the notice to relevant parties promptly and ensure it is clearly visible and easily accessible.
Who needs urgent field safety notice?
01
Companies or organizations responsible for products or equipment with safety issues.
02
Safety regulators and authorities.
03
Any individuals or entities who may be affected by the safety issue.
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What is urgent field safety notice?
An urgent field safety notice is a notification issued by a manufacturer or regulatory authority to inform users about potential safety issues related to a medical device or product that may pose risks to health.
Who is required to file urgent field safety notice?
Manufacturers, authorized representatives, and distributors of medical devices are typically required to file an urgent field safety notice when a safety risk is identified.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, the responsible entity must include details such as the nature of the risk, affected products, recommended actions for users, and contact information for follow-up.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to promptly inform users about risks associated with a product, enabling them to take necessary precautions or actions to mitigate potential harm.
What information must be reported on urgent field safety notice?
Information on the product involved, the nature of the risk, safety measures, affected lots or batches, and instructions for users must be reported in an urgent field safety notice.
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