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Field Safety Notice BU IT Systems page 1 of 3 FSN: 2018IGTBST0202019, 26 February Doc ID: DHF338331/ XCR609190023URGENT Field Safety Notice Medical Device: MultiDiagnostEleva, Urodiagnost, OmniDiagnostEleva

How to fill out field safety notice form

How to fill out field safety notice form

1. Obtain the field safety notice form from the relevant authority or organization.
2. Fill in all the required fields with accurate and up-to-date information.
3. Include details about the safety concern or issue that prompted the need for the form.
4. Attach any supporting documentation or evidence related to the safety concern.
5. Review the completed form to ensure all information is correct and legible.
6. Submit the form to the appropriate contact or department as specified on the form.

Who needs field safety notice form?

1. Manufacturers of products that have been identified as potentially unsafe.
2. Distributors or retailers who sell products that have been recalled or deemed unsafe.
3. Regulatory agencies or authorities responsible for monitoring product safety.

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What is field safety notice form?

The field safety notice form is a document used to report any potential risks or safety issues related to a medical device.

Who is required to file field safety notice form?

Manufacturers, authorized representatives, and distributors are required to file field safety notice forms.

How to fill out field safety notice form?

The form should be filled out with detailed information about the safety issue, the affected medical device, and any actions taken or proposed to address the issue.

What is the purpose of field safety notice form?

The purpose of the form is to ensure the safety and effectiveness of medical devices by promptly addressing any identified risks.

What information must be reported on field safety notice form?

Information such as the nature of the safety issue, the affected medical device model, serial numbers, and contact information for the manufacturer must be reported on the form.