FDA Medical Device Adverse Event Report (MDR)

FDA Medical Device Adverse Event Reporting Made Simple

When a medical device causes or contributes to an adverse event, timely and accurate reporting to the FDA is not just a regulatory obligation—it's critical to patient safety. The FDA Medical Device Reporting (MDR) regulation (21 CFR Part 803) requires manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems.

This FDA Medical Device Adverse Event Report (MDR) template streamlines the complex process of documenting device malfunctions, serious injuries, and deaths associated with medical devices. Built specifically for medical device manufacturers, quality assurance teams, regulatory affairs professionals, and healthcare facilities, this form ensures you capture every required data point while maintaining compliance with FDA submission timelines.

Who Needs This Form?

Medical device adverse event reporting is mandatory for:

• Medical device manufacturers documenting device malfunctions, serious injuries, or deaths
• Quality assurance and regulatory affairs teams managing post-market surveillance
• Healthcare facilities and device user facilities required to report under MDR regulations
• Clinical research organizations tracking device-related adverse events in trials
• Importers and distributors of medical devices in the United States
• Risk management professionals conducting root cause analysis and corrective actions

What This Template Captures

Our comprehensive MDR form is structured to align with FDA reporting requirements:

Reporter Information: Capture details about the individual or organization submitting the report, including contact information and reporter type (manufacturer, user facility, distributor, or other).

Device Information: Document complete device details including device name, model number, catalog number, serial/lot number, manufacturer information, device classification, and whether the device was single-use or reusable.

Event Information: Record the date and time of the event, location where it occurred, detailed event description, event type (malfunction, injury, death, or other), and whether the device was returned to the manufacturer for evaluation.

Patient Information: Collect relevant patient demographic data (de-identified per HIPAA requirements), treatment information, patient outcomes, whether hospitalization was required, and current patient status.

Event Sequence: Document the complete sequence of events leading to the adverse event, initial device use, any warning signs or malfunctions, and immediate actions taken.

Manufacturer Evaluation: Capture manufacturer investigation findings, root cause analysis, device analysis results, corrective actions implemented, and preventive measures to avoid recurrence.

FDA Submission Details: Track submission timeline, FDA report number (if available), submission method, and follow-up reporting requirements.

This form uses conditional logic to show or hide relevant sections based on event severity, device type, and patient outcome—ensuring reporters only see fields relevant to their specific situation while maintaining comprehensive documentation.

Why Paperform for FDA Compliance?

Regulatory compliance forms require precision, security, and seamless workflow integration. Here's why healthcare organizations and medical device manufacturers trust Paperform for MDR reporting:

Secure, Compliant Infrastructure: Paperform is SOC 2 Type II compliant with robust data encryption, access controls, and audit trails. While not HIPAA compliant, the platform provides enterprise-grade security suitable for de-identified adverse event reporting. All submissions are stored securely with role-based access controls to protect sensitive device and event information.

Automated Workflows with Stepper: Once an adverse event report is submitted, time is critical. Connect this form to Stepper to automatically trigger your compliance workflow—notify quality assurance teams, create tickets in your quality management system, initiate manufacturer investigations, set FDA submission deadline reminders, and route reports for approval before submission. Stepper can even track the 30-day reporting timeline for manufacturers and ensure no deadlines are missed.

Integration with Quality Management Systems: Paperform integrates seamlessly with quality management platforms, document management systems, CRMs, and project management tools. Push adverse event data to your QMS, log events in tracking spreadsheets, update regulatory databases, and maintain comprehensive audit trails without manual data entry.

Conditional Logic for Complex Reporting: FDA MDR requirements vary based on event severity, device classification, and reporter type. This template uses Paperform's advanced conditional logic to dynamically adjust required fields—ensuring manufacturers see evaluation sections, user facilities see appropriate reporting pathways, and everyone captures the data relevant to their specific reporting obligation.

Professional, Brand-Aligned Design: Even compliance forms benefit from clear, professional design. This template uses a clean, medical-industry-appropriate aesthetic with logical section organization, helpful field descriptions, and progress indicators. Embed it on your quality portal or share it as a standalone link for field representatives and clinical staff.

Built-in Calculations and Date Tracking: Automatically calculate time elapsed since the event, flag reports approaching FDA submission deadlines, and use calculation fields to determine reporting requirements based on event severity and device classification.

FDA MDR Reporting Requirements: Key Timelines

Understanding FDA timelines is critical for compliance:

• 5-Day Reports: Device malfunctions that require remedial action to prevent unreasonable risk of substantial harm must be reported within 5 working days
• 30-Day Reports: Deaths, serious injuries, and certain malfunctions must be reported within 30 calendar days of becoming aware of the event
• Follow-Up Reports: Additional information discovered during investigation must be submitted as supplemental reports

This template includes date tracking and automatic timeline calculations to help you stay compliant with these critical deadlines.

Streamline Post-Market Surveillance with Paperform

Medical device adverse event reporting is just one piece of post-market surveillance. Paperform supports the full spectrum of regulatory compliance and quality management needs for healthcare organizations:

• Customer complaint intake and trending analysis
• Non-conformance reports and corrective/preventive action (CAPA) tracking
• Vigilance reporting for international markets (EU MDR, Health Canada, etc.)
• Product quality deviation reports
• Risk assessment documentation

With Paperform's flexible form builder, you can customize this MDR template to align with your organization's specific quality management procedures, integrate with existing systems, and maintain the detailed documentation required during FDA inspections and audits.

Get Started with Compliant Adverse Event Reporting

Whether you're a medical device manufacturer, healthcare facility, or regulatory professional, this FDA Medical Device Adverse Event Report template provides the structure and compliance framework you need to fulfill your MDR obligations. The combination of secure data collection, workflow automation via Stepper, and seamless integrations makes Paperform the ideal platform for managing complex regulatory reporting requirements.

Start with this template and customize it to match your device types, organizational workflow, and specific reporting scenarios—then let Paperform and Stepper handle the automation, notifications, and compliance tracking so your team can focus on patient safety and continuous improvement.