Get Mandatory Problem Reporting Procedure Template

This guide aims to assist users in accurately completing the Mandatory Problem Reporting Procedure Template online. By following these steps, users can ensure their reports are thorough and compliant with regulatory expectations.

Follow the steps to successfully complete the reporting template.

1. Click ‘Get Form’ button to obtain the Mandatory Problem Reporting Procedure Template and open it in your preferred online editor.
2. In the 'Reporter Information' section, outline your details, including whether you are the manufacturer or importer, and provide your contact information. Ensure that you include the reporter's file number and Health Canada file number if applicable.
3. Move to the 'Incident Information' section. Here, classify the incident based on its seriousness and note the date it occurred. Also, record the date when you were first made aware of the problem and detail any consequences for the patient.
4. Complete the 'Medical Device Information' section with specifics about the medical device involved, including its trade name, control number, and device classification.
5. In the 'Complainant Information' section, provide details about the complainant, including their relationship to the incident and contact information.
6. Navigate to the 'Investigation Information' section. Here, describe the investigative actions taken, including timelines and any corrective actions required. Conclude by detailing the root cause of the problem if known.
7. Once all sections are complete, review your entries for accuracy. You can then save your changes, download a copy of the form, and choose to print or share it as needed.

Start completing the Mandatory Problem Reporting Procedure Template online to ensure timely and accurate reporting.