MIRADRY SYSTEM
Received Jun 3, 2025 · Event occurred May 5, 2025
Report 3008082710-2025-70010 · MDR key 22134889
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
40 YR · Female
- Burn(s)
- Burn(s)
Narrative
Additional Manufacturer Narrative
A DATA REVIEW FOR HANDPIECE SERIAL NUMBER (B)(6) WAS PERFORMED ON 05/30/2025 THE REVIEW INDICATES THE SYSTEMS IS OPERATING AS INTENDED AND THERE WERE NO DEVICE MALFUNCTIONS THAT CONTRIBUTED TO THIS EVENT.
Description of Event or Problem
PATIENT WITH UNDERARM BURNS, PATIENT ENCOUNTERED BURN AND SKIN PEELED DURING TREATMENT OF RIGHT AXILLA. PHYSICIAN USED MEBO OINTMENT ON THE BURNED SKIN. PHYSICIAN STATED THAT THEY APPLIED THE KY GEL AS PER THE PROTOCOL. HOWEVER, THEY PUT SOME MORE PRESSURE ON THE ARM DURING ENERGY DELIVERY.