BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3261610 · Received July 23, 2013

    Report

    Report Number
    3005011024-2013-00009
    Event Type
    Other
    Date Received
    July 23, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE SAMPLE IS NOT AVAILABLE FOR EXAMINATION BY DEROYAL. THE VENDOR FOR THE STYROFOAM TRAY, (B)(4), 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

    VARIOUS COMPONENTS (BULB SYRINGE, SUCTION TUBING AND GRADUATE PITCHER) WERE INDENTED INTO FOAM TRAY CAUSING ITEM TO STICK TO TRAY RESULTING IN FOAM PARTICLES STICKING TO COMPONENT OR IN LOOSE FOAM PARTICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342266 DEROYAL KDD-KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC. 31911595

    Patients

    Seq Age Sex Outcome Treatment
    1 Other