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Mandatory medical device problem reporting form for industry

Mandatory problem reporting procedure template 2025

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The document outlines the procedures for mandatory reporting of medical device problems in Canada, detailing how industry stakeholders (manufacturers and importers) should submit reports to the Canada Vigilance - Medical Device Problem Reporting Program. It includes instructions on completing the reporting form, which requires information about the reporter, incident details, medical device specifics, complainant information, and investigation actions. The document emphasizes that submitting a report does not imply fault and provides contact information for submissions.

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Click ‘Get Form’ to open the mandatory problem reporting procedure template in the editor.
Begin with Section A: Reporter Information. Fill in your role as either the manufacturer or importer, and provide your contact details including name, email, and phone number.
In Section B: Incident Information, classify the incident by indicating whether it is a 10-day or 30-day report. Provide the date of the incident and any patient consequences.
Proceed to Section C: Medical Device Information. Enter the trade/brand name of the device, control/lot/serial number, and other relevant details such as expiration date and device classification.
Complete Section D: Complainant Information by providing details about the complainant, including their name and contact information.
Finally, fill out Section E: Investigation Information if applicable. Document any investigative actions taken and root causes identified.

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2018	4.6 Satisfied (41 Votes)
2011	4.3 Satisfied (44 Votes)

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We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

What is the MDR?

The EU MDR, short for European Union Medical Device Regulation, is a comprehensive set of rules and directives applicable to all medical devices intended to be manufactured and sold in Europe. The purpose of the MDR is to ensure the safety and effectiveness of medical devices in the European market.

Which form is used for mandatory adverse event reporting to the FDA?

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

What system is used by the FDA to monitor device performance and detect potential safety issues?

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products.

What does MDR stand for in medical terms?

multidrug-resistant; multidrug resistance. Second-line drugs are essential for treating multidrug-resistant and extensively drug-resistant tuberculosis (MDR TB and XDR TB).

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