InjuryOUB
MIRADRY SYSTEM
Received Aug 5, 2022 · Event occurred Jun 22, 2022
Report 3008082710-2022-70027 · MDR key 15179537
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
19 YR · Male
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
- Partial thickness (Second Degree) Burn
- Full thickness (Third Degree) Burn
Narrative
Additional Manufacturer Narrative
A REVIEW OF SYSTEM DATA INDICATED NO MALFUNCTION WITH THE MIRADRY CONSOLE
Description of Event or Problem
THE TREATING PHYSICIAN CONTACTED MIRADRY TO REPORT A PATIENT THAT DEVELOPED A PARTIAL THICKNESS BURN IN THEIR RIGHT AXILLA AND A FULL THICKNESS BURN IN THEIR LEFT AXILLA.