Get Canada 110180 2018-2025

Filling out the Canada 110180 form, also known as the mandatory medical device problem reporting form, is crucial for reporting issues related to medical devices marketed in Canada. This guide provides detailed instructions to assist users in completing the form accurately and efficiently.

Follow the steps to fill out the mandatory medical device problem reporting form successfully.

1. Click ‘Get Form’ button to obtain the form and open it in the editor.
2. Fill out the reporter information section. Indicate whether the reporter is the manufacturer or importer, and provide contact details including name, email, telephone, and fax number.
3. Complete the reporter file number and Health Canada file number fields, if applicable. Specify the type of report — whether it is preliminary, update, final, or a combination. Provide the date submitted and the name and address of the manufacturer and importer.
4. In the incident information section, classify the incident by whether it is a 10-day or 30-day report. Also, provide the date of the incident and the date the reporter became aware of it.
5. Detail the patient consequences and incident specifics, including any devices, equipment, or drugs involved in the incident.
6. In the medical device information section, fill out the trade/brand name, control/lot/serial number, expiration date, and device classification. Provide the device license number and identification number as well.
7. Describe the complainant information, including their name, health care facility (if applicable), address, and contact information.
8. Complete the investigation information section by detailing the investigative actions taken, root cause of the problem, and corrective actions implemented. This is necessary for final reports.
9. Review all filled sections for accuracy. Once complete, save changes, download, print, or share the form as necessary.

Complete your Canada 110180 form online to ensure proper reporting of medical device issues.