FDA Adverse Event
Injury
Summary report: N
CODMAN DISPOSABLE VEIN STRIPPER
MDR report key: 369174
·
Received January 2, 2002
Report
- Report Number
- 1226348-2002-00003
- Event Type
- Injury
- Date Received
- January 2, 2002
- Report Date
- December 5, 2001
- Manufacturer
- CODMAN & SHURTLEFF, INC.
- Product Code
- GAJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AFFILIATE IN FRANCE REPORTS THE DISTAL PORTION OF THE VEIN STRIPPER BROKE AND STAYED TOGETHER WITH THE OLIVE IN THE PATIENT'S VEIN. THE PROCEDURE WAS DEPLYAED WHILE THE SURGEON MADE ANOTHER INCISION IN ORDER TO REMOVE THE BROKEN PORTION OF THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN DISPOSABLE VEIN STRIPPER | STRIPPER, VEIN, DISPOSABLE | GAJ | CODMAN & SHURTLEFF, INC. | NA | CT648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |