BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113738 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00057
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    January 2, 2013
    Report Date
    April 29, 2014
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K091792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER, AND NO LOT NUMBER INFO WAS GIVEN SO AN EVALUATION CANNOT BE PERFORMED AS TO THE ROOT CAUSE OR ACTUAL NATURE OF THE PROBLEM. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A POSSIBLE DELAMINATION, AS CHOKING IS POSSIBLE AS A RESULT OF DELAMINATION.

    Description of Event or Problem · 1

    DIRECTIONS WERE FINE. THE SOFT SILICONE AT THE FRONT OF THE MOUTH GUARD SEPARATED FROM THE HEARD LOWER SURFACE LEAVING AN OPENING OR GAP. MAY NOT HAVE SEALED WELL IN THE INJECTION MOLD? I MAILED FORMS A FEW DAYS AGO, BUT FORGOT THE UPC CODE. ATTACHED TO THE FORM IS MY RECEIPT COPY AND UPC CODE. THE ORIGINAL WAS SENT EARLIER (RECEIPT). THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262610 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening