BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIGHT GUARD

    MDR report key: 2802534 · Received October 19, 2012

    Report

    Report Number
    1825660-2012-00004
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 18, 2012
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    112879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER WOKE UP WITH PIECES OF THE NIGHT GUARD STUCK IN HER THROAT AFTER ONLY TWO NIGHTS OF WEARING THE DEVICE. ALTHOUGH NO HARM CAME TO THE CONSUMER, THE SMALL BITS COULD POSSIBLY HAVE BEEN ASPIRATED AND CAUSED SERIOUS INJURY. MITIGATING CIRCUMSTANCES ARE THAT THE CONSUMER IS AN EXTREME TOOTH GRINDER AND CLENCHER, AND WAS USING THIS DEVICE ON THE ADVICE OF HER DENTIST WHILE SHE AWAITED A PROFESSIONAL DEVICE FROM HER DENTIST FOR EXTREME GRINDING. ALSO, THE NIGHT GUARD IS NOT SUPPOSED TO DETERIORATE IN THIS MANNER. HOWEVER, THE DEVICE IS NOT DESIGNED FOR EXTREME TOOTH GRINDING WHICH RESULTS IN EXCESSIVE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIGHT GUARD OBR RANIR LLC 016756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other