BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZER

    MDR report key: 3792622 · Received March 30, 2014

    Report

    Report Number
    3792622
    Event Type
    Malfunction
    Date Received
    March 30, 2014
    Date of Event
    November 13, 2013
    Report Date
    March 30, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DOX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN THE BALANCE WIRE WAS REMOVED, IT HAD UNRAVELED. THE DEVICE REMAINED INTACT WITH NO RETAINED PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187123 STABILIZER WIRE, GUIDE, CATHETER DOX CORDIS CORPORATION * 70.613483

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR LIKELY, ALTHOUGH NOT SPECIFIED