Medical Device Adverse Event Reporting Form

Medical device adverse event reporting is a critical component of patient safety and regulatory compliance in healthcare settings. This Medical Device Adverse Event Reporting Form provides healthcare professionals with a structured, efficient way to document and report complications, malfunctions, or unexpected outcomes related to medical devices.

Whether you're a hospital administrator, clinical staff member, or quality assurance professional, accurate adverse event reporting helps identify device safety issues, protect future patients, and fulfill regulatory obligations to bodies like the FDA. This form streamlines the entire reporting process by capturing essential details about the device, the event, the patient impact, and necessary follow-up actions.

Key features of this template include:

• Comprehensive device identification and tracking fields
• Structured event description with severity classification
• Patient impact assessment and clinical outcome documentation
• Manufacturer and regulatory notification tracking
• Reporter contact information for follow-up inquiries
• Conditional logic to capture relevant details based on event type

Built on Paperform's flexible platform, this template can be customized to match your facility's specific reporting protocols while maintaining compliance with regulatory requirements. The form's professional design ensures that critical information is never missed, and submissions can be automatically routed to your quality assurance team, risk management department, or directly to device manufacturers.

Streamline post-submission workflows with Stepper

Once an adverse event report is submitted, time is of the essence. Connect this form to Stepper to automatically trigger your incident response protocol: notify the quality assurance team, create a case file in your safety management system, send preliminary notifications to manufacturers, and schedule follow-up reviews—all without manual handoffs. Stepper's AI-native automation ensures that serious events receive immediate attention while routine reports follow your standard review process.

This template is designed for hospitals, clinics, medical device companies, and healthcare facilities that need to maintain rigorous safety reporting standards. With Paperform's SOC 2 Type II compliance and robust security features, your sensitive adverse event data remains protected throughout the reporting and investigation process.