Adverse Event Reporter

Prerequisites

• Complaint information received
• Investigation completed
• Device information available
• Regulatory requirements identified

Best Practices

• Assess reportability promptly
• Document decision rationale
• Track reporting timelines
• Integrate with risk management

Process Integration

This skill integrates with the following processes:

• Post-Market Surveillance System Implementation
• Clinical Evaluation Report Development
• Medical Device Risk Management (ISO 14971)
• EU MDR Technical Documentation

Dependencies

• FDA MAUDE database
• EUDAMED system
• MedDRA coding dictionary
• Complaint management systems
• Risk management databases

Configuration

adverse-event-reporter:
  reporting-systems:
    - FDA-MDR
    - EU-vigilance
    - Health-Canada
    - TGA
  report-types:
    - death
    - serious-injury
    - malfunction
    - field-safety-corrective-action
  timelines:
    - 30-day
    - 5-day
    - annual

Output Artifacts

• Reportability assessments
• FDA Form 3500A drafts
• EU vigilance reports
• Trend analysis reports
• PSUR contributions
• FSCA notifications
• Risk management updates
• Corrective action plans

Quality Criteria

• Reportability assessed per regulations
• Reports submitted within timelines
• MedDRA coding accurate
• Trend analysis comprehensive
• Risk management updated
• Documentation audit-ready