InjuryOUB
MIRADRY SYSTEM
Received Mar 24, 2025 · Event occurred Feb 7, 2025
Report 3008082710-2025-70003 · MDR key 21682707
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
38 YR · Female
- Swelling/ Edema
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
A DATA REVIEW WAS CONDUCTED AGAINST THE DEVICE AND THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.
Description of Event or Problem
PATIENT PRESENTED WITH REDNESS POSSIBLE ULCER ON LEFT AXILLA 2 WEEKS POST PROCEDURE AND WAS IMMEDIATELY SEEN AND PLACED ON AN ORAL ABX. 500 MG OF DURCIEF. ISSUE IS NOW RESOLVING.