BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3350043 · Received September 10, 2013

    Report

    Report Number
    3005011024-2013-00027
    Event Type
    Other
    Date Received
    September 10, 2013
    Date of Event
    August 28, 2013
    Report Date
    August 28, 2013
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: THE MEDICAL CENTER REPORTED THAT THE FOAM TRAY WAS CUT ZIGZAGGED ALLOWING FOAM PARTICLES TO GET ON GOWNS AND OTHER ITEMS IN THE TRAY. DEROYAL: THE SAMPLE IS NOT AVAILABLE FOR EXAMINATION BY DEROYAL. THE VENDOR FOR THE STYROFOAM TRAY, CROWN PACKAGING CORP., HAS BEEN NOTIFIED OF THIS ISSUE. FOAM TRAYS HAVE BEEN REMOVED FROM ALL FINISHED GOODS AT DEROYAL, AND REPLACED BY PLASTIC PLATFORM TRAYS.

    Description of Event or Problem · 1

    THE MEDICAL CENTER REPORTED THAT THE FOAM TRAY WAS CUT ZIGZAGGED ALLOWING FOAM PARTICLES TO GET ON GOWNS AND OTHER ITEMS IN THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452150 DEROYAL KDD-KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 32480109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other