FDA Adverse Event
Injury
Summary report: N
MIRADRY SYSTEM
MDR report key: 20302711
·
Received September 25, 2024
Report
- Report Number
- 3008082710-2024-70016
- Event Type
- Injury
- Date Received
- September 25, 2024
- Report Date
- August 28, 2024
- Manufacturer
- MIRADRY INC.
- Product Code
- OUB
- PMA / PMN Number
- K1311162
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PENDING ADDITIONAL INFORMATION FROM ACCOUNT. A FOLLOW UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 0
(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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1097902 | MIRADRY SYSTEM | MICROWAVE DERMATOLOGIC SYSTEM | OUB | MIRADRY INC. | MN-MD4000-MC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |