BEUDAMED
    FDA Adverse Event Summary report: N

    CODMAN DISPOSABLE VEIN STRIPPER

    MDR report key: 2219327 · Received August 15, 2011

    Report

    Report Number
    2219327
    Date Received
    August 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 28, 2011
    Manufacturer
    DEPUY
    Product Code
    GAJ
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING VEIN STRIPPING OF LEFT LEG, THE END NUB OF STRIPPING DEVICE BROKE OFF INSIDE THE LEG. THE BROKEN PART WAS VISIBLE AND WAS RETRIEVED BY AN INCISION IN THE LEG. ALL PIECES OF THE DEVICE ARE ACCOUNTED FOR AND SAVED FOR QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN DISPOSABLE VEIN STRIPPER CODMAN VEIN STRIPPER GAJ DEPUY DISPOSABLE VEIN STRIPPER CA672

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR