MIRADRY SYSTEM
Received Jul 2, 2026 · Event occurred May 5, 2026
Report 3008082710-2026-70016 · MDR key 25700308
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
24H0025-KR
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
44 YR · Female
- Burn(s)
Narrative
Additional Manufacturer Narrative
THERE WAS NO DEVICE ISSUE REPORTED OR TREATMENT DATA AVAILABLE FOR REVIEW. A REVIEW OF THE PRODUCTION RECORDS SHOWS THE DEVICE PASSED ALL FINAL INSPECTIONS AND TESTS. BASED ON THE INFORMATION PROVIDED, THIS INCIDENT HAS BEEN DETERMINED TO BE A RARE RISK OF THE PROCEDURE WITH NO EVIDENCE OF DEVICE MALFUNCTION.
Description of Event or Problem
CLINIC REPORTED PATIENT WITH SUSPECTED BURN IN LEFT AXILLA OBSERVED DURING FOLLOW UP 24 DAYS POST MIRADRY TREATMENT. DRESSING WAS APPLIED, AND THE PATIENT SENT HOME. DURING THE NEXT FOLLOW-UP VISIT 5 DAYS LATER (29 DAYS POST TREATMENT) NECROSIS WAS OBSERVED (WOUND SIZE 1.5 CM X 1 CM). PATIENT WAS REFERRED TO A PLASTIC SURGERY CLINIC.