MIRADRY SYSTEM
Received Apr 11, 2026 · Event occurred Feb 19, 2026
Report 3008082710-2026-70007 · MDR key 24849513
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
47 YR · Male
- Abscess
Narrative
Description of Event or Problem
CLINIC REPORTED PATIENT WITH RIGHT AXILLA CELLULITIS AND ABSCESS FORMATION. ORAL ANTIBIOTIC (CLYNDAMICIN) AND I&D WITH WOUND PACKING PROVIDED, BUT FOUND SYMPTOMS HAD WORSENED. PROVIDED BACTRIM AND NOW RESOLVING. THEY TESTED FOR MRSA AND IT WAS NEGATIVE, CULTURES OF WOUND ARE STILL PENDING. THE PATIENT HAS SENSITIVE SKIN, INGROWN HAIRS HISTORY. CLINIC BELIEVES THE PATIENT WAITED TO CALL AND THAT THE INFECTION MAY HAVE WORSENED DUE TO INACTION. THE PATIENT WAS BEING SEEN BY THE CLINIC DAILY FOR DEBRIDEMENT AND PACKING OF THE ABSCESS. THE PATIENT WAS EXPECTED TO BE SEEN (B)(6) 2026. CLINIC HAS NOT RESPONDED TO REQUESTS FOR PATIENT CONDITION UPDATE.
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.