adverse-event-reporter
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
npx skills add a5c-ai/babysitter --skill adverse-event-reporter --agent claude-code
Same command for any agent — swap --agent for codex, cursor, copilot.
Weekly change comes from our own snapshots, not the repository page — it measures attention, not adoption.
# 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
- Purpose
- Capabilities
- Usage Guidelines
- When to Use
- Prerequisites
- Best Practices
- Process Integration
- Dependencies
- Configuration
- Output Artifacts
- Quality Criteria
What does the adverse-event-reporter skill do?
Adverse event monitoring and reporting skill for MDR/MEDWATCH compliance
How do I install it?
Run `npx skills add a5c-ai/babysitter --skill adverse-event-reporter --agent claude-code` — it drops the skill into your project so the agent can pick it up. Swap the --agent value for codex, cursor or copilot if you use one of those.
Where does this skill come from?
From a5c-ai/babysitter, a repository with 1,642 stars. We read it straight from the repository tree rather than a submitted listing, so what you see here is what is actually published.
Is a popular skill a good skill?
Not necessarily. Stars measure attention, not adoption — a repository can trend for a week and be abandoned. That is why we show the weekly change from our own snapshots next to the total, instead of a single flattering number.