BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL TRAY

    MDR report key: 1943959 · Received December 14, 2010

    Report

    Report Number
    1943959
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    #1 WHEN FILLING THE STERILE BOWL, DURING PREPARATION A SHARP, HARD, CLEAR, AND BUBBLE-FILLED PIECE OF DEBRIS FLOATED TO THE TOP OF THE STERILE BOWL.#2 A SECOND STERILE KIT WAS OPENED AFTER THE FIRST WAS FOUND TO BE UNUSABLE. "CARDBOARD" FLECKS WERE OBSERVED IN THE STERILE WIRE BOWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL TRAY KIT, SURGICAL INSTRUMENT DISPOSABLE KDD AVID MEDICAL, INC. HENF-012-08 716580
    2 FEMORAL TRAY KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD AVID MEDICAL, INC HENF-012-08 716580

    Patients

    Seq Age Sex Outcome Treatment
    1 *