InjuryOUB
MIRADRY SYSTEM
Received Jun 17, 2022 · Event occurred May 7, 2022
Report 3008082710-2022-70020 · MDR key 14738780
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
Female
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
THE PATIENT CONTACTED THE TREATING PHYSICIAN 9 DAYS POST TREATMENT STATING THAT THEY NOTICED A WOUND IN THE RIGHT ARM PIT. THE WOUND WAS TREATED WITH POLYSPAM AND GAUZE. THE PATIENT WAS DIAGNOSED WITH A WOUND ULCERATION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR 5 DAYS.
Additional Manufacturer Narrative
THE SYSTEM HAD NO UNUSUAL ERRORS DURING THE (B)(6) 2022 TREATMENT AND A REVIEW OF OTHER TREATMENT DATES FOUND NO ISSUES WITH THE SYSTEM. THE SYSTEM IS OPERATING NORMALLY.