FDA Adverse Event
Injury
Summary report: N
MIRADRY SYSTEM
MDR report key: 20101520
·
Received August 29, 2024
Report
- Report Number
- 3008082710-2024-70015
- Event Type
- Injury
- Date Received
- August 29, 2024
- Date of Event
- April 19, 2024
- Report Date
- August 14, 2024
- Manufacturer
- MIRADRY INC.
- Product Code
- OUB
- PMA / PMN Number
- K1311162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A REVIEW OF THE DEVICE DATA INDICATED NO ISSUE WITH THE DEVICE THAT WOULD HAVE CAUSED THE ADVERSE EVENT.
Description of Event or Problem · 0
COMPLAINT FROM THE CLINIC STATING PATIENT DEVELOPED HIDRADENITIS SUPPURATIVA. THE WOUND WAS DRAINED AND SUTURES WERE APPLIED. WOUND TREATED WITH BACITRACIN OINTMENT AND WASH WITH SOAP AND WATER. PATIENT DID NOT KNOW OF ANY UNDERLYING SKIN CONDITION. SMALL AREAS WERE STILL INFLAMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1765769 | MIRADRY SYSTEM | MICROWAVE DERMATOLOGIC SYSTEM | OUB | MIRADRY INC. | MN-MD4000-MC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Female |