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12. October 2017To Whom it may concernURGENT FIELD SAFETY NOTICEColoplast A/S Hosted 1 3050 Hamlet Denmark Tel.: +45 4911 1111 www.coloplast.com Corner. 69749917Ref. FRMML20151006PR30xx & VS30xx Voluntary

How to fill out urgent field safety notice

How to fill out urgent field safety notice

1. To fill out an urgent field safety notice, follow these steps:
2. Start by opening the safety notice form.
3. Fill in the required information such as the product name, model number, and serial number.
4. Provide a detailed description of the safety issue or potential hazard.
5. Include any relevant attachments such as photos, diagrams, or test reports.
6. Clearly state the recommended actions to address the safety issue.
7. Include contact information for further inquiries or clarification.
8. Review the completed notice for accuracy and completeness before submitting.
9. Submit the filled-out form to the appropriate authority or organization as instructed.

Who needs urgent field safety notice?

1. An urgent field safety notice is typically needed by manufacturers, distributors, or organizations responsible for the safety of a specific product or equipment.
2. It is used to communicate safety concerns or issues to customers, suppliers, regulatory bodies, or any other relevant stakeholders who may be affected by the product in question.
3. These notices are particularly important when there is a potential risk of injury, damage, or any other negative consequences related to product usage or operation.

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What is urgent field safety notice?

Urgent field safety notice is a communication issued by a manufacturer or distributor to inform regulatory authorities and users about a safety concern with a medical device.

Who is required to file urgent field safety notice?

Manufacturers or 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 be filled out with detailed information about the safety concern, affected devices, and recommended actions.

What is the purpose of urgent field safety notice?

The purpose of urgent field safety notice is to alert regulatory authorities and users about a potential safety issue with a medical device and provide guidance on how to address it.

What information must be reported on urgent field safety notice?

Information such as the identification of the device, the nature of the safety concern, affected lot numbers, distribution details, and recommended actions must be reported on urgent field safety notice.