BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3234101 · Received July 12, 2013

    Report

    Report Number
    3005011024-2013-00002
    Event Type
    Other
    Date Received
    July 12, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 20, 2013
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL FOR EVALUATION. THE VENDOR FOR THE STYROFOAM TRAY, CROWN PACKAGING CORP, HAS BEEN NOTIFIED OF THIS ISSUE. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    FOR ORAL SURGERY CASES, WE USE A PACK THAT CONTAINS TUBING, SYRINGES, SPONGES, AND OTHER SUCH ITEMS WHICH ARE PRE-PACKAGED BY DEROYAL. THESE ITEMS ARE PLACED ON A STYROFOAM TRAY AND (I BELIEVE) STERILIZED. ON AT LEAST TWO OCCASIONS, THE STYROFOAM HAS FLAKED OFF AND ADHERED TO EITHER TUBING OR A BULB SYRINGE, LEADING TO THE POTENTIAL OF THE STYROFOAM GETTING INTO THE PATIENT'S CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324858 DEROYAL PACK, ORAL MAJOR KDD DEROYAL INDUSTRIES, INC. 31769437

    Patients

    Seq Age Sex Outcome Treatment
    1 Other