InjuryOUB
MIRADRY SYSTEM
Received Aug 24, 2022 · Event occurred Jul 27, 2022
Report 3008082710-2022-70030 · MDR key 15288119
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Lot number
222
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
Description of Event or Problem
PATIENTS ARE EXPERIENCING SMALL BURNS IN UNDERARMS.
Additional Manufacturer Narrative
A REVIEW OF CONSOLE DATA INDICATED NO ISSUES WITH THE DEVICE THAT WOULD CAUSE BURNS.