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