BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4128542 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00766
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 20, 2014
    Report Date
    April 30, 2014
    Manufacturer
    RANIR CORPORATION
    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 INFORMATION 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

    "SHE HAS USED OUR PRODUCTS IN THE PAST, AND THIS TIME THE PROTECTOR SEEMED SMALLER. THERE WASN'T ENOUGH MATERIAL TO FIT AROUND HER TEETH, SO SHE HAD TO TRY A SECOND TIME. THIS IS HER THIRD TIME USING OUR PRODUCT AND THIS TIME THE MOUTH PIECE SEPARATED FROM TOP TO BOTTOM INTO TWO PIECES AFTER TWO USES. SHE SAID OUR PRODUCTS WORKED WELL IN THE PAST."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262312 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR CORPORATION GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening