MIRADRY SYSTEM
Received Apr 11, 2026 · Event occurred Feb 26, 2026
Report 3008082710-2026-70008 · MDR key 24849265
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
15H1289
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
18 YR · Male
- Skin Erosion
Narrative
Additional Manufacturer Narrative
REVIEW OF ADVERSE EVENTS AND AVAILABLE TREATMENT DATA FOR THE INVOLVED DEVICE DID NOT REVEAL ANY OTHER SIMILAR ISSUES OR SUGGESTION OF POTENTIAL DEVICE PROBLEM. REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEPS AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.
Description of Event or Problem
CLINIC REPORTED PATIENT WITH ULCERATION (SIZE OF A PENNY) 1/4 INCH THICK HALO PINK IN COLOR WITH REGRANULATION NOTED. A SMALL BRUISE HAD BEEN NOTED IMMEDIATELY FOLLOWING TREATMENT. UNSURE IF THIS IS A BURN OR AN AREA THAT WAS CAUSED BY FRICTION. THE PATIENT IS NONCOMPLIANT WITH POST RECOMMENDATION OF NO UPPER BODY EXERCISE. CEFUROXIME WAS PRESCRIBED AND WOUND IS IMPROVING. PATIENT USING A HYDROCOLLOID DUODENUM PATCH TO COVER THE AREA. CLINIC IS CONTINUING TO MONITOR PATIENT CONDITION.