FDA Adverse Event
Other
Summary report: N
CODMAN & SHURTLEFF, INC.
MDR report key: 250373
·
Received November 17, 1999
Report
- Report Number
- 250373
- Event Type
- Other
- Date Received
- November 17, 1999
- Date of Event
- October 20, 1999
- Report Date
- October 21, 1999
- Manufacturer
- CODMAN & SHURTLEFF, INC PRODUCT COMPLAINT DEPT.
- Product Code
- GEI
- Report Source
- User Facility report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
WHILE PERFORMING TONSILLECTOMY, A BURN TO THE MOUTH OCCURRED. IT IS SUSPECTED THAT THE BIPOLAR FORCEPS CONTACTED THE SIDE OF THE MOUTH AND CAUSED THIS BURN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN & SHURTLEFF, INC. | MALIS BIPOLAR COAGULATOR & FORCEPS | GEI | CODMAN & SHURTLEFF, INC PRODUCT COMPLAINT DEPT. | CMC-I | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Other | FORCEPS 80-2961, LOT # 9909N. |