FDA Adverse Event
Other
Summary report: N
UNK
MDR report key: 539847
·
Received July 14, 2004
Report
- Report Number
- 539847
- Event Type
- Other
- Date Received
- July 14, 2004
- Date of Event
- May 9, 2004
- Report Date
- July 14, 2004
- Manufacturer
- UNK
- Product Code
- GEG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KY, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
COBB ELEVATOR BROKE OFF IN PATIENT- RUSTED AT HANDLE JUNCTION. RUST PARTICLES ON STERILE FIELD, IN WOUND. WOUND CLEANED OUT BY PHYSICIAN. WOUND IRRIGATED WITH BACITRACIN IRRIGATION. ALL STERILE PERSONNEL CHANGED GLOVES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | COBB ELEVATOR | GEG | UNK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |