BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIROFLEX

    MDR report key: 2444976 · Received February 6, 2012

    Report

    Report Number
    2444976
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 30, 2012
    Report Date
    February 6, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    DURING TESTING OF THE CATHETER, IT WAS NOTED TO HAVE A KINK AND HOLE IN IT. THEREFORE, DID NOT USE IN PATIENT. A DIFFERENT CATHETER WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIROFLEX SPIROFLEX ANGIOJET POSSIS CATHETER DXE MEDRAD, INC. 106553-001 103982

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR NO OTHER THERAPIES