FDA Adverse Event
Injury
Summary report: N
CODMAN
MDR report key: 302247
·
Received October 13, 2000
Report
- Report Number
- 302247
- Event Type
- Injury
- Date Received
- October 13, 2000
- Date of Event
- July 12, 2000
- Report Date
- July 28, 2000
- Manufacturer
- CODMAN JOHNSON & JOHNSON MEDICAL LTD
- Product Code
- GAJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
WHILE PERFORMING VEIN STRIPPING PROCEDURE, VEIN STRIPPER DEVICE BROKE WHILE STILL IN PT'S LEG. X-RAYS WERE TAKEN TO LOCATE DEVICE IN PT. TWO ADD'L INCISIONS WERE REQUIRED TO RETRIEVE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CODMAN | DISPOSABLE VEIN STRIPPER | GAJ | CODMAN JOHNSON & JOHNSON MEDICAL LTD | * | KR 417 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |