InjuryOUB
MIRADRY SYSTEM
Received Nov 10, 2021 · Event occurred Oct 8, 2021
Report 3008082710-2021-00015 · MDR key 12787769
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC-US
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
32 YR · Female
- Skin Infection
- Skin Infection
Narrative
Description of Event or Problem
THE PATIENT HAD MIRADRY TREATMENT DONE ON 10/8 AND RETURNED TO THE CLINIC WITH SWELLING IN HER UNDERARM ON 10/14. THE CLINIC GAVE THE PATIENT ANTIBIOTICS. THE SWELLING WORSENED A DAY LATER. THEY DRAINED SOME OF THE LIQUID FROM HER UNDERARM AT THE CLINIC. THE PATIENT WAS ADMITTED INTO THE ER, AND WAS DIAGNOSED WITH NECROTIZING FASCIITIS. THE PATIENT'S SKIN WAS INFECTED RESULTING IN SKIN REMOVAL MEASURING 12X12X4IN AT THE HOSPITAL. THEY WERE ALSO GIVEN A SKIN GRAFT.