Adverse Event Report
A formal document completed by a clinician to record an unintended, harmful outcome following a cosmetic dermatology procedure, required by regulatory bodies and clinic governance frameworks.
Full Definition
An adverse event report (AER) is a standardised clinical document used to record, investigate, and communicate unintended outcomes associated with cosmetic dermatology treatments, including device-related complications, injection reactions, and unexpected patient responses. Regulatory bodies such as the MHRA (UK) and the FDA (US) require reportable adverse events to be logged using designated forms within specified timeframes. Editors working on clinical governance documents, consent packs, or patient safety communications must ensure the term is not abbreviated to 'AE report' without prior definition. 'Adverse event' should not be conflated with 'side effect', as the latter implies an expected, predictable response to treatment.
Usage
Usage note: Do not substitute 'side-effect report' or 'complication report'—these are distinct concepts. 'Adverse event' includes all unintended outcomes regardless of expectedness; 'side effect' implies a known, expected response.
In Context
- "Completion of an adverse event report was mandatory within 72 hours of the patient developing signs of vascular occlusion." — Clinic governance policy
- "The editor standardised 'adverse reaction report' to 'adverse event report' throughout the quality assurance manual to align with regulatory terminology." — Regulatory document editing note