BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 3261619 · Received July 23, 2013

    Report

    Report Number
    3005011024-2013-00011
    Event Type
    Other
    Date Received
    July 23, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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

    FOAM TRAY HAD LOOSE FOAM PARTICLES THAT COULD CONTAMINATE STERILE FIELD AND PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342197 DEROYAL KDD - KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD DEROYAL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other