BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 3994115 · Received July 24, 2014

    Report

    Report Number
    1825660-2014-00882
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 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 EVENT OCCURRED IN (B)(6). THIS COMPLAINT HAS NOT BEEN CONFIRMED. DEVICE NOT RETURNED TO MANUFACTURER, AND NO LOT NUMBER INFO WAS GIVEN SO AN EVAL 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 AAS A POSSIBLE DELAMINATION, AS CHOKING IS POSSIBLE AS A RESULT OF DELAMINATION.

    Description of Event or Problem · 1

    AFTER USING IT FOR NO MORE THAN 5 DAYS, I HAD TO STOP. IT SEEMED AS THROUGH THE GEL PORTION WAS DETACHING AND BITTEN THROUGH, ALMOST PEELING FROM THE PLASTIC BASE WHICH IN TURN WAS WAKING ME IN THE MIDDLE OF THE NIGHT GAGGING BECAUSE THE PIECES WERE COMING APART. I'M NOT SURE IF IT IS BECAUSE MY GRINDING WAS SO AGGRESSIVE OR THAT THE GEL WAS TOO THIN. IN ANY CASE, IT WAS NOT AIDING ANY LONGER BECAUSE IT IS ALMOST 2 SEPARATE PIECES AT THAT POINT-BEING THE HARD BASE AND THE SOFTER GEL MATERIAL ON TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435091 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening