InjuryOUB
MIRADRY SYSTEM
Received May 20, 2022
Report 3008082710-2022-70016 · MDR key 14453619
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
- Full thickness (Third Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Description of Event or Problem
THE TREATING PHYSICIAN REACHED OUT TO REPORT A PATIENT THAT DEVELOPED A FULL THICKNESS BURN A FEW DAYS AFTER TREATMENT.
Additional Manufacturer Narrative
THOUGH THE TREATMENT OF THE BURN IS NOT KNOWN, A REVIEW OF TREATMENTS IN (B)(6) 2022 SHOWED NO ISSUES WITH THE SYSTEM. THE SYSTEM APPEARS TO BE FUNCTIONING NORMALLY.