InjuryOUB
MIRADRY SYSTEM
Received Sep 25, 2024 · Event occurred Apr 8, 2024
Report 3008082710-2024-70017 · MDR key 20302828
Device
Generic name
Microwave Dermatologic System
Manufacturer
Miradry Inc.Model number
MN-MD4000-MCCatalog number
MN-MD4000-MC
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Female
- Hematoma
- Hematoma
Narrative
Description of Event or Problem
(B)(6) VISITED (B)(6) AND WAS INFORMED THAT 3 PATIENT COMPLAINTS RELATED TO HEMATOMA POST MIRADRY TX ONE WEEK. THE PATIENTS HAVE HAD CULTURES AND DRAINING OF THE HEMATOMA WITHOUT RESOLUTION AND HAVE BEEN CULTURED FOR STAPHYLOCOCCUS. UPDATE: RECEIVED FM0164 PATIENT ABSCESS LEFT AND RIGHT, NODULES WITH DISCOMFORT TREATED WITH I+D AND ORAL ANTIBIOTICS.
Additional Manufacturer Narrative
PENDING ADDITIONAL INFORMATION FROM ACCOUNT. A FOLLOW UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION IS RECEIVED.