MIRADRY SYSTEM
Received Jan 8, 2026 · Event occurred Oct 20, 2025
Report 3008082710-2026-70001 · MDR key 24016113
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
18H0670-US
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR · Male
- Abscess
Narrative
Additional Manufacturer Narrative
TREATMENT DATA REVIEW SHOWED NO SYSTEM MALFUNCTIONS. 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. PATIENT APPEARED TO HAVE HIDRADENITIS SUPPURATIVE (HS). PATIENTS WITH KNOWN HS SHOULD NOT BE TREATED AND IN RARE CASES, PATIENTS WITH THE UNDERLYING CONDITION MAY PRESENT WITH HS POST TREATMENT. THE ISSUE WAS REPORTED AS RESOLVING, HOWEVER, FOLLOW UP WITH A DERMATOLOGIST IS RECOMMENDED.
Description of Event or Problem
PATIENT TREATED (B)(6) 2025 CONTACTED CLINIC (B)(6) 2025 COMPLAINING OF SWOLLEN RASH UNDER ARMS BILATERALLY. PATENT WAS INSTRUCTED TO HEAT AND APPLY TOPICAL CORTISONE CREAM TO AREAS AND MONITOR FOR FEVER. ON (B)(6) 2025, PATIENT REACHED OUT STATING THE RASHES HAD OPENED AND DRAINED CLEAR FLUID. NO FEVER OR CHILLS NOTED AT THE TIME. CEPHALEXIN WAS PRESCRIBED WITH PATIENT DIRECTED TO CONTINUE WARM COMPRESSES AND HYDROCORTISONE CREAM. ON (B)(6) 2025, PATIENT REPORTED SCARRING TO UNDERARMS AND HARD NODULES WITH NO PAIN OR FEVER.