adverse-event-reporter

Adverse Event Reporter Skill

Purpose

The Adverse Event Reporter Skill supports adverse event monitoring and regulatory reporting for medical devices, ensuring compliance with FDA MDR requirements and EU vigilance obligations.

Capabilities

• MDR reportability assessment
• FDA Form 3500A population assistance
• MEDWATCH submission guidance
• EU vigilance reporting templates
• Trend analysis and signal detection
• PSUR data compilation
• Field safety corrective action templates
• Complaint coding (MedDRA)
• Risk assessment updates
• Corrective action tracking
• Regulatory notification timelines

Usage Guidelines

When to Use

• Assessing adverse event reportability
• Preparing regulatory reports
• Conducting trend analyses
• Managing field actions

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