FDA Adverse Event
Malfunction
Summary report: N
TRUSCULPT
MDR report key: 3266973
·
Received February 26, 2013
Report
- Report Number
- 2954354-2013-00007
- Event Type
- Malfunction
- Date Received
- February 26, 2013
- Date of Event
- January 28, 2013
- Report Date
- January 28, 2013
- Manufacturer
- CUTERA, INC.
- Product Code
- PBX
- PMA / PMN Number
- K122389
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SMALL BURN IN AREA OF TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83787 | TRUSCULPT | PBX | CUTERA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |