BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR CHECK FLO INTRODUCER

    MDR report key: 1833351 · Received September 8, 2010

    Report

    Report Number
    MW5017380
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 25, 2010
    Report Date
    September 8, 2010
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PULLED THE SHEATH BACK AND OVER THE AORTA BIFURCATION TO PUT A WIRE IN AN EXCHANGE FOR A SHORTER SHEATH AND THE HUB CAME CLEAR OFF THE END OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR CHECK FLO INTRODUCER FLEXOR CHECK FLO INTRODUCER DYB COOK INCORPORATED 2461934

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other