BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4114877 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00352
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    December 17, 2013
    Report Date
    April 29, 2013
    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 MFR, 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

    THE DIRECTIONS ABOVE SAY TO BITE DOWN UNTIL YOUR TEETH MAKE CONTACT WITH THE HARD BASE LAYER. AFTER HAVING MY PROTECTOR SEPARATE TWICE AFTER DAYS (AT MOST A WEEK). I EMAILED CUSTOMER SERVICE AND WAS TOLD THAT YOU SHOULD NOT BITE DOWN HARD OR IT WILL CAUSE IT TO SEPARATE IF YOU GO THROUGH. THIS SHOULD BE CLARIFIED. I WOULD LIKE ANOTHER PROTECTOR TO TRY AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262621 NITE GUARD MOUTHGUARD, OVE THE COUNTER OBR RANIR LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening