FDA Adverse Event
Injury
Summary report: N
JOHNSON & JOHNSON (CODMAN)
MDR report key: 488882
·
Received October 1, 2003
Report
- Report Number
- 488882
- Event Type
- Injury
- Date Received
- October 1, 2003
- Date of Event
- August 27, 2003
- Report Date
- September 3, 2003
- Manufacturer
- JOHNSON & JOHNSON HEALTHCARE
- Product Code
- GAJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DIAGNOSIS: VARICOSE VEIN. PROCEDURE: SAPHENOUS STRIPPING. INCIDENT: WHEN REMOVING DEEP VEIN STRIPPER FROM PT'S LEG, NOTICED SMALL BULLET TIP WAS MISSING. ULTRASOUND SHOWED NO FINDINGS, FOUND ON X-RAY, LOCATED BEHIND KNEE. REQUIRED INCISION ON BACK OF KNEE FOR REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JOHNSON & JOHNSON (CODMAN) | DEEP VEIN STRIPPER | GAJ | JOHNSON & JOHNSON HEALTHCARE | * | FV495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |