Mandatory Medical Device Problem Reporting Form for Industry: Fill out & sign online

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Click ‘Get Form’ to open the Mandatory Medical Device Problem Reporting Form in our platform's editor.
Begin with Section A: Reporter Information. Fill in your type (manufacturer or importer) and provide your contact details, including name, email, and phone number.
In Section B: Incident Information, classify the incident by indicating if it’s a 10-day or 30-day report. Provide the date of the incident and details about patient consequences.
Proceed to Section C: Medical Device Information. Enter the trade/brand name, control/lot/serial number, and device classification. Ensure all relevant fields are completed accurately.
Complete Section D: Complainant Information by providing details about the complainant and their contact information.
Finally, fill out Section E: Investigation Information if applicable. Document any investigative actions taken and root causes identified.

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