Free printable template · PDF
Incident and Adverse Event Report Form
A form for recording anything that went wrong or nearly did: a treatment complication, an allergic reaction, a needlestick, a fall, or a device failure. Complete it the same day, stick to facts, and have your medical director review it.
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Incident and Adverse Event Report Form
MedSpaBinder
Clinic
Date and time of incident
Location in clinic
Complete the same day. For a needlestick or blood exposure, follow your exposure control plan first.
Type of incident
Adverse reaction to treatment
Suspected vascular occlusion
Allergic reaction / anaphylaxis
Burn or skin injury
Needlestick / blood exposure
Fall or injury on premises
Medication or product error
Device or equipment failure
Other:
Person affected
Patient (use chart #)
Staff member
Visitor
Name or chart #
Staff involved
Treatment or task being done
Product / device and lot #
What happened (facts only, in order)
Immediate actions taken
Medical director notified (name, time)
Emergency services called? (time)
Follow-up arranged for the person affected
Reported to manufacturer / FDA MedWatch (date)
Follow-up, outcome and changes made
Completed by (name, signature)
Date
Reviewed by medical director
Date
What to report
Anything that caused, or could have caused, harm: a complication or reaction to a treatment, an emergency, a needlestick or other exposure, an injury on the premises, a product or medication error, or a device that failed. Near misses are worth reporting too; they're how you fix a problem before it hurts someone.
How to fill it in
- Write it the same day, while details are fresh.
- Stick to facts: what was seen, done and said, and when. Leave out opinions and blame.
- Record the product and lot number, or the device, so it can be traced and reported.
- Have your medical director review it and record what will change so it doesn't happen again.
Reporting outside the clinic
- Serious adverse events and product problems with drugs, fillers or devices can be reported to FDA through MedWatch, and to the manufacturer.
- A needlestick or blood exposure follows your exposure control plan, including the confidential medical evaluation OSHA requires.
- Your state may require certain events to be reported to a board or agency. Your medical director and insurer should know what applies.
Questions
Does the incident report go in the patient's chart?
The clinical facts and treatment go in the chart. Many clinics keep the incident report itself in a separate file for quality review. Ask your attorney or insurer how to handle it in your state.
Should we report near misses?
Yes. A near miss, such as the wrong product drawn up and caught before injection, is the cheapest lesson you'll get. Record it the same way and note what changed.
Sources
General guidance, not legal or medical advice. Requirements vary by state; follow your medical director and product labels.