InjuryOUB
MIRADRY SYSTEM
Received Aug 19, 2022 · Event occurred Jul 9, 2022
Report 3008082710-2022-70029 · MDR key 15262449
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
Male
- Ulcer
- Ulcer
Narrative
Description of Event or Problem
THE PATIENT DEVELOPED AN ULCER.
Additional Manufacturer Narrative
A REVIEW OF CONSOLE DATA INDICATED THAT THE SYSTEM IS FUNCTIONING AS INTENDED.