FDA Adverse Event
Injury
Summary report: Y
MIRADRY SYSTEM
MDR report key: 14593603
·
Received June 3, 2022
Report
- Report Number
- 3008082710-2022-70019
- Event Type
- Injury
- Date Received
- June 3, 2022
- Date of Event
- July 12, 2021
- Report Date
- June 3, 2022
- Manufacturer
- MIRADRY INC.
- Product Code
- OUB
- UDI-DI
- 00853419006008
- PMA / PMN Number
- K1311162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FACILITY NAME AND CONTACT WERE INTENTIONALLY LEFT BLANK. A REVIEW OF CONSOLE DATA WAS PERFORMED AND INDICATED THE CONSOLE WAS WORKING AS INTENDED.
Description of Event or Problem · 0
CUSTOMER HAS A PATIENT WHO IS EXPERIENCING INTERMITTENT NUMBNESS AND TINGLING IN HER PINKY AND RING FINGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1801485 | MIRADRY SYSTEM | MICROWAVE DERMATOLOGIC SYSTEM | OUB | MIRADRY INC. | MN-MD4000-MC | 222 | 00853419006008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | Required Intervention | MIRADRY HANDPIECE: 14H0843 |