BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHANTOM

    MDR report key: 3174451 · Received June 6, 2013

    Report

    Report Number
    3174451
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    February 27, 2013
    Report Date
    June 5, 2013
    Manufacturer
    TEDAN SURGICAL INNOVATIONS, LLC
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    SMALL PIECES OF METAL SHAVINGS WERE FOUND ON THE SCREW DRIVER FROM THE PHANTOM/SHADOWLINE RETRACTOR SET. IT WAS REMOVED RIGHT AWAY AND NO SHAVINGS WERE LOCATED IN THE WOUND. (DID NOT REACH THE PATIENT).WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPENING AND OPERATING THE RETRACTOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251982 PHANTOM RETRACTOR SET GAD TEDAN SURGICAL INNOVATIONS, LLC * 17781-004

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR