InjuryOUB
MIRADRY SYSTEM
Received Sep 22, 2025 · Event occurred Mar 31, 2025
Report 3008082710-2025-70032 · MDR key 23106593
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
19H0446-EU
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Abscess
- Abscess
Narrative
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.
Description of Event or Problem
PATIENT DEVELOPED INFECTION THAT REQUIRED INCISION AND A PRESCRIPTION OF ANTIBIOTICS. COM#: (B)(4) WAS CREATED TO DOCUMENT INITIAL REPORT FROM ACCOUNT.