BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM

    MDR report key: 2802521 · Received September 17, 2012

    Report

    Report Number
    2802521
    Event Type
    Malfunction
    Date Received
    September 17, 2012
    Date of Event
    May 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    COVIDIEN
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    COIL CAME WITHOUT SHEATH OR SHEATH GOT STUCK IN THE HOUSING AND THEREFORE THE COIL COULD NOT BE USED. THEY TRIED FIVE AND ALL WITH SAME PROBLEM, THEY WERE RETURN TO THE REPRESENTATIVE, NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN * 9326897
    2 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN * 9320458
    3 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN * 9361886
    4 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN * 9295101
    5 AXIUM DEVICE, NEUROVASCULAR EMBOLIZATION HCG COVIDIEN * 9235787

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR