MIRADRY SYSTEM
Received May 15, 2026 · Event occurred Apr 7, 2026
Report 3008082710-2026-70011 · MDR key 25194062
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
16H0047
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
36 YR · Male
- Skin Infection
Narrative
Description of Event or Problem
CLINIC REPORTED PATIENT WITH REDNESS IN BOTH AXILLA DIAGNOSED AS BILATERAL INFECTION, RESOLVING WITH NO FURTHER FOLLOW UP REQUIRED. ANTIBIOTICS WERE PRESCRIBED BUT IT IS UNKNOWN WHETHER THE ANTIBIOTICS WERE ADMINISTERED. THE CLINIC ATTRIBUTED THE BILATERAL INFECTION TO THE PATIENT WORKING OUTDOORS FOR SEVERAL HOURS POST TREATMENT AND SWEATING WITHOUT CLEANSING THE TREATED AREAS.
Additional Manufacturer Narrative
CLINIC STATED INFECTION WAS DUE TO PATIENT FAILURE TO REFRAIN FROM STRENUOUS ACTIVITY AND TO KEEP TREATMENT AREA CLEAN AS DIRECTED IN AFTER CARE INSTRUCTIONS. THERE HAVE BEEN NO SIMILAR PREVIOUS REPORTS FROM THIS CLINIC OR TRENDS IDENTIFIED REQUIRING FURTHER INVESTIGATION OR ACTION. THIS APPEARS TO BE AN ISOLATED EVENT AND WILL BE TRACKED AND TRENDED UNDER ROUTINE QUALITY SYSTEM PROCESSES. THERE WAS NO DEVICE ISSUE REPORTED OR IDENTIFIED DURING REVIEW OF TREATMENT DATA.