How do I install the Adverse Event Reporter skill?

Run npx skillmds@latest add a5c-ai/adverse-event-reporter in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

What does the Adverse Event Reporter skill do?

Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance It is listed under Coding & Dev Tools on SkillMD.

Is Adverse Event Reporter safe to use?

This skill has not completed SkillMD's automated safety review yet. Independent scanners report: SkillSpector: PASS, Skill Scanner: PASS. Capability flags: docs only. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Adverse Event Reporter?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Adverse Event Reporter free to use?

Yes. Installing skills from SkillMD is free, and the skill stays under its author's original license.

Who published Adverse Event Reporter?

a5c-ai (@a5c-ai) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Adverse Event Reporter by a5c-ai — Agent Skill

Name: Adverse Event Reporter
Rating: 4.2 (5 reviews)
Author: a5c-ai

File contents

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

---name: adverse-event-reporterdescription: Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance--- # 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 ```yaml 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

Frequently asked questions

Adverse Event Reporter