InjuryOUB
MIRADRY SYSTEM
Received Jul 1, 2025 · Event occurred Apr 5, 2025
Report 3008082710-2025-70015 · MDR key 22379243
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A DATA REVIEW WAS CONDUCTED AGAINST THE DEVICE AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.
Description of Event or Problem
PATIENT REPORTED REDNESS AND FEVER. THEY PERFORMED A PUNCTURE DUE TO SUSPECTED HEMATOMA BUT IT WAS NOT. SWELLING AND DRAINAGE FROM AREA WAS OBSERVED FROM SWOLLEN AREA. TWO SPOTS FOUND ON THE LEFT ARMPIT CENTER (DIAMETER 2 CM), THESE WERE REMOVED AND FOLLOWED UP BY A DOCTOR. PATIENT IS RECOVERING.