BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILSON-COOK

    MDR report key: 2622614 · Received June 7, 2012

    Report

    Report Number
    MW5025832
    Event Type
    Malfunction
    Date Received
    June 7, 2012
    Date of Event
    May 5, 2012
    Report Date
    June 7, 2012
    Manufacturer
    WILSON-COOK MEDICAL
    Product Code
    FDR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PTG-26-6-BII-NG CAME OUT OF PACKAGING WITH KINK IN IT AND UNABLE TO PASS THE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON-COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPINCTEROTOME FDR WILSON-COOK MEDICAL G22143 W2791380

    Patients

    Seq Age Sex Outcome Treatment
    1