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