InjuryOUB
MIRADRY SYSTEM
Received May 20, 2022
Report 3008082710-2022-70017 · MDR key 14453517
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
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.
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.