MIRADRY SYSTEM
Received Jun 14, 2023 · Event occurred Nov 9, 2022
Report 3008082710-2023-70025 · MDR key 17132082
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
44 YR · Female
- Full thickness (Third Degree) Burn
- Full thickness (Third Degree) Burn
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 FELT BURNING AND EXTREME PAIN DURING THE NUMBING PROCESS. THEY SHOWED IMMEDIATE BRUISING BEFORE THE HEAT WAS ADMINISTERED. THE DOCTOR DECIDED TO DO EXTRA NUMBING ON THE SIDE THAT WAS BRUISING. THEY FELT HEAT ONLY ON THE SIDE THAT HAD BRUISING. SHE ENDED UP WITH BURNS WHERE THE BRUISING HAD BEEN AND THERE WAS A HOLE IN HER UNDERARM. THEY SAID THE TISSUE DIED AND THE DOCTOR DID SEVERAL TREATMENTS ON HER TO HELP CLEAN UP THE DEAD TISSUE.