MIRADRY SYSTEM
Received Jun 3, 2026 · Event occurred Apr 21, 2026
Report 3008082710-2026-70014 · MDR key 25369346
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
14H2202
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR · Male
- Abscess
Narrative
Additional Manufacturer Narrative
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
PATIENT PRESENTED WITH ABSCESS IN LEFT AXILLA 4 WEEKS POST MIRADRY TREATMENT. ABSCESS WAS INCISED, DRAINED, AND PACKED. PATIENT WAS PLACED ON ANTIBIOTICS. PATIENT WAS STRONGLY ADVISED NOT TO SCUBA DIVE THE NEXT WEEK. PATIENT RETURNED TO CLINIC 3 DAYS LATER FOR IRRIGATION AND PACKING. ABSCESS WAS IMPROVING. AT FOLLOW UP 2 DAYS LATER, SITE HAD CONTINUED TO IMPROVE AND STERILE DRESSING WAS APPLIED. ISSUE WAS REPORTED AS RESOLVING WITH FULL RESOLUTION EXPECTED.