MIRADRY SYSTEM
Received Nov 12, 2025 · Event occurred Oct 13, 2025
Report 3008082710-2025-70041 · MDR key 23539023
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
15H1432-EU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
33 YR · Male
- Skin Infection
- Skin Infection
Narrative
Description of Event or Problem
CLINIC REPORTED PATIENT TREATED (B)(6) 2025) WITH PERSISTENT COMPLICATIONS 8 MONTHS POST TREATMENT. TWO MONTHS POST TREATMENT (B)(6) 2025): SWELLING IN RIGHT AXILLA. THREE MONTHS POST TREATMENT (B)(6) 2025): PALPABLE FIRM NODULE, PURULENT DISCHARGE AFTER ASPIRATION, AND NO CLEAR ABSCESS FORMATION. GENTLE MASSAGE AND FUCIDIN OINTMENT FOR 1 WEEK PRESCRIBED. FIVE MONTHS POST TREATMENT (B)(6) 2025): INCREASED SWELLING AND CHILL-LIKE SYMPTOMS WITH NO FEVER. ABSCESS WAS DRAINED. PATIENT STARTED ON FLUCLOXACILLIN WITH LIMITED IMPROVEMENT AND AREA FEELING FLATTER. CULTURE REFLECTED SPORADIC GROWTH OF SKIN FLORA. PRESENTATION AT TIME OF REPORT (B)(6) 2025) SHOWED IMPROVED BUT PERSISTENT INDURATION, ERYTHEMA, AND WOULD FLUID DISCHARGE FROM LATERAL LESION WITH PRESSURE.
Additional Manufacturer Narrative
REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICE CONFIRMED MANUFACTURING STEP AND PROCESSES WERE MET AND FOLLOWED. PRODUCT MET FINAL INSPECTION AND TESTING REQUIREMENTS PRIOR TO SHIPMENT.