InjuryOUB
MIRADRY SYSTEM
Received Mar 28, 2022 · Event occurred Feb 18, 2022
Report 3008082710-2022-70007 · MDR key 13930244
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
222
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
16 YR · Female
- Abscess
- Abscess
Narrative
Description of Event or Problem
IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT'S ARM WAS RENDERED USELESS. SHE COMPLAINED OF SEVERE PAIN AND LACK OF RANGE OF MOTION. VISIBLE ABSCESS APPEARED WEDNESDAY PROGRESSIVELY GOT WORSE, SHE WAS ADMITTED TO EMERGENCY . SHE WAS GIVEN PROPOFOL AND FENTANYL TO PERFORM DRAINAGE OF THE ABSCESS.