InjuryOUB
MIRADRY SYSTEM
Received Sep 8, 2023 · Event occurred Jul 30, 2023
Report 3008082710-2023-70036 · MDR key 17712125
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
Unknown
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA WAS COMPLETED AND FOUND NO ISSUE WITH THE SYSTEM THAT WOULD CAUSE THE ADVERSE EVENT.
Description of Event or Problem
RECEIVED A COMPLAINT FORM FROM TIM STATING ON 7/30 A TREATMENT WAS COMPLETED, HOWEVER DURING THE PATIENTS RETURN VISIT IT WAS NOTICED THE PATIENT HAD BURNS.