InjuryOUB
MIRADRY SYSTEM
Received Jul 27, 2023
Report 3008082710-2023-70030 · MDR key 17406227
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 INDICATED NO ISSUE WITH THE DEVICE THAT WOULD HAVE CAUSED BLISTERS OR BURNS.
Description of Event or Problem
PATIENT HAD BURNS AND BLISTERS AFTER MIRADRY TREATMENT.