InjuryOUB
MIRADRY SYSTEM
Received May 19, 2023 · Event occurred Mar 23, 2023
Report 3008082710-2023-70021 · MDR key 16970409
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
42 YR · Female
- Skin Erosion
- Skin Erosion
Narrative
Description of Event or Problem
THE PATIENT DEVELOPED DARK SPOTS IMMEDIATELY AFTER THEIR SECOND TX. THE SPOT ON THEIR LEFT SIDE OPENED UP AND DEVELOPED INTO AN ULCER.
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA WAS PERFORMED AND FOUND NO ISSUES WITH THE DEVICE THAT CAUSE THE ADVERSE EVENT.