InjuryOUB
MIRADRY SYSTEM
Received Apr 7, 2023 · Event occurred Feb 21, 2023
Report 3008082710-2023-70013 · MDR key 16702188
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 PERFORMED AND FOUND NO ISSUES WITH THE DEVICE THAT CAUSE THE ADVERSE EVENT.
Description of Event or Problem
PATIENT DEVELOPED 3 DOTS (HYPERPIGMENTATION) AND CLUSTERED- APPEARED TO BE A BURN UPON EXAM.