InjuryOUB
MIRADRY SYSTEM
Received Jun 3, 2026 · Event occurred Apr 15, 2026
Report 3008082710-2026-70013 · MDR key 25369315
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
27 YR · Female
- Abscess
Narrative
Description of Event or Problem
CLINIC REPORTED PATIENT WITH ABSCESS IN RIGHT AXILLA, INCISED, DRAINED AND PACKED. PATIENT WAS PLACED ON ORAL ANTIBIOTICS AND ANTIBIOTIC OINTMENT APPLIED. PATIENT WAS HEALING WITH EXPECTATION OF FULL RECOVERY AT 4 WEEKS POST TREATMENT.
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.