InjuryOUB
MIRADRY SYSTEM
Received Aug 29, 2024 · Event occurred Apr 19, 2024
Report 3008082710-2024-70015 · MDR key 20101520
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
27 YR · Female
- Abscess
- Abscess
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE DEVICE DATA INDICATED NO ISSUE WITH THE DEVICE THAT WOULD HAVE CAUSED THE ADVERSE EVENT.
Description of Event or Problem
COMPLAINT FROM THE CLINIC STATING PATIENT DEVELOPED HIDRADENITIS SUPPURATIVA. THE WOUND WAS DRAINED AND SUTURES WERE APPLIED. WOUND TREATED WITH BACITRACIN OINTMENT AND WASH WITH SOAP AND WATER. PATIENT DID NOT KNOW OF ANY UNDERLYING SKIN CONDITION. SMALL AREAS WERE STILL INFLAMED.