MIRADRY SYSTEM
Received Feb 8, 2023
Report 3008082710-2023-70003 · MDR key 16325653
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Increase in Pressure
- Increase in Pressure
Patient
36 YR · Female
- Necrosis
- Necrosis
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA WAS PERFORMED AND FOUND NO ISSUES WITH THE DEVICE THAT CAUSE THE ADVERSE EVENT. DEVICE WAS USED OFF LABEL ON A RESIDUAL LIMB.
Description of Event or Problem
PATIENT RECEIVED 2ND TREATMENT FOR RESIDUAL LIMB HYPERHIDROSIS; DEVELOPED RETIFORM PURPURA AND SKIN NECROSIS AS WELL AS POPLITEAL FOSSA DVT. STARTED ON ANTI-COAGULANT. PREDNISONE TAPER. KEFLEX FOR EMPIRIC ABX COVERAGE. WOUND CARE. OFFICIAL DIAGNOSIS IS VASCULOPATHY AND DEEP VEIN THROMBOSIS. THIS WAS OFF LABEL FOR RESIDUAL LIMB(TRANSTIBIAL AMPUTATION) HYPERHIDROSIS. IT WAS HER LEFT LEG/RESIDUAL LIMB.