Get Incident Report Format

Filling out the Incident Report Format online is essential for documenting any incidents related to medical devices. This guide provides users with clear, step-by-step instructions to ensure accurate and complete submissions.

Follow the steps to effectively complete the Incident Report Format.

1. Click the ‘Get Form’ button to obtain the form and open it in your preferred online editor.
2. Begin by filling out the administrative information section. Include the name and address of the national competent authority, the date of the report, and any reference numbers assigned by both the manufacturer and the authority if available.
3. Next, provide information about the submitter. Indicate the status of the submitter and fill in their details based on whether they are the manufacturer, authorized representative, or another role.
4. In the manufacturer information section, enter the manufacturer's name, contact person, address, and other contact details including phone and email.
5. If applicable, detail the authorized representative’s information including their name, contact person, and address.
6. Fill out the submitter’s information if it differs from the manufacturer or authorized representative sections. Provide full details including names and contacts.
7. In the medical device information section, classify the device and provide details such as nomenclature codes, model numbers, and any associated accessories.
8. Complete the incident information by detailing the date of the incident, a narrative description, and the number of patients and devices involved.
9. Provide patient information if applicable, including outcome and any remedial actions taken by the healthcare facility.
10. Fill in the healthcare facility information, including the name of the facility and contact details.
11. Provide preliminary comments or analysis by the manufacturer, including any corrective actions taken.
12. For the final report, detail the results of the manufacturer’s investigation and any further investigation plans.
13. Finally, affirm the information is correct and sign the form with the date and other required details.
14. Once all fields are completed, save your changes, then download, print, or share the form as needed.

Start filling out your Incident Report Format online today for accurate documentation.