FDA Adverse Event
Injury
Summary report: N
CODMAN DISPOSABLE VEIN STRIPPER
MDR report key: 492065
·
Received October 28, 2003
Report
- Report Number
- 1226348-2003-00237
- Event Type
- Injury
- Date Received
- October 28, 2003
- Date of Event
- September 25, 2003
- Report Date
- September 30, 2003
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- GAJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE VEIN STRIPPER OLIVE PULLED AWAY FROM THE REST OF THE PRODUCT AND WAS LEFT IN THE PT'S LEG. THE SURGEON MADE A LARGER INCISION TO REMOVE THE OLIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN DISPOSABLE VEIN STRIPPER | STRIPPER, VEIN, DISPOSABLE | GAJ | CODMAN & SHURTLEFF, INC. | NA | FV496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |