FDA Adverse Event
Other
Summary report: N
RET, TEBBETTS F/O 90MM X 30MM
MDR report key: 510618
·
Received February 10, 2004
Report
- Report Number
- 1038548-2004-00008
- Event Type
- Other
- Date Received
- February 10, 2004
- Date of Event
- January 6, 2004
- Report Date
- January 10, 2004
- Manufacturer
- SNOWDEN PENCER, INC.
- Product Code
- GAD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
DURING AN OPERATION TO CHANGE BREAST IMPLANTS, THE PT RECEIVED A SUPERFICIAL 2ND DEGREE BURN TO THE THORAX. A LIGHT CABLE WAS USED. (DOCTORS) DID OBSERVE OVERHEATING WITH THIS UNIT.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RET, TEBBETTS F/O 90MM X 30MM | * | GAD | SNOWDEN PENCER, INC. | 88-1086 | 773496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |