BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4114999 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00387
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    August 7, 2012
    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 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

    THE FIRST ONE I COULDN'T GET TO FIT EVEN THOUGH I FOLLOWED DIRECTIONS. THE SECOND ONE FIT OK (NOT PERFECT) BUT AFTER 2 WEEKS WEARING, THE TWO LAYERS BEGAN TO SEPARATE AND NOW IT IS DIFFICULT TO WEAR. THE PRICE PAID FOR THESE 2 MOUTH NIGHT PROTECTORS WAS A SIZEABLE INVESTMENT AND I WOULD EXPECT IT TO WORK AS ADVERTISED, AND CERTAINLY NOT TO SEPARATE AFTER A COUPLE WEEKS WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262479 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC. GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening