InjuryOUB
MIRADRY SYSTEM
Received May 15, 2025 · Event occurred May 1, 2025
Report 3008082710-2025-70006 · MDR key 22028013
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
26 YR · Male
- Skin Erosion
- Skin Erosion
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 COMPLAINING OF POST INFLAMMATORY ULCERS ON LEFT AXILLA ARM POST TX. ON (B)(6) 2025 SEE UPDATE: ULCERATIVE LESION WAS OBSERVED. SURGICAL DEBRIDEMENT WAS CONDUCTED, FOLLOWED BY SALINE IRRIGATION AND PROTECTION WITH APPROPRIATE DRESSING. THE PATIENT CONDITION HAS IMPROVED AND THIS WILL NOT BE REPORTED TO REGULATORY AUTHORITIES.