InjuryOUB
MIRADRY SYSTEM
Received May 24, 2023 · Event occurred Jan 28, 2023
Report 3008082710-2023-70022 · MDR key 16995303
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Female
- Skin Erosion
- Skin Erosion
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA WAS PERFORMED AND FOUND NO ISSUES WITH THE DEVICE THAT CAUSE THE ADVERSE EVENT.
Description of Event or Problem
PATIENT DEVELOPED AN INFECTION THAT RESULTED IN AN ULCER THAT NEEDED TO BE DRAINED TWICE AND WAS PUT ON MULTIPLE COURSES OF ANTIBIOTICS.