FDA Adverse Event
Injury
Summary report: N
SKYLAR VEIN STRIPPER
MDR report key: 34727
·
Received June 27, 1996
Report
- Report Number
- 34727
- Event Type
- Injury
- Date Received
- June 27, 1996
- Date of Event
- May 8, 1996
- Report Date
- June 24, 1996
- Manufacturer
- UNKNOWN
- Product Code
- DWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGICAL PROCEDURE OF STRIPPING OF RIGHT GREATER SAPHENOUS, TIP OF THE VEIN STRIPPER INSTRUMENT CAME OFF. THE BROKEN PORTION WAS RETRIEVED BY THE SURGEON. PORTABLE X-RAY FOR FOREIGN BODY WAS PERFORMED, WITH NONE FOUND. WOUNDS WERE CLOSED WITH STAPLES AND THE PT RECOVERED WITH NO ADD'L EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SKYLAR VEIN STRIPPER | VEIN STRIPPER | DWQ | UNKNOWN | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |