BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113830 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00373
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    July 10, 2012
    Report Date
    April 29, 2014
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K120103
    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 EVAL CANNOT BE PERFORMED AS TO THE ROOT CAUSE OR ACTUAL NATURE OF THE PROBLEM. NO INJURY WAS REPORTED, NO MED 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

    NOT SURE. THE MOUTH PIECES DIDN'T STAY TOGETHER. THE FIRST ONE FELL APART AFTER A MONTH (B)(6). THE SECOND ONE JUST IS NOT FITTING RIGHT (B)(6). I HAVE HAD A NIGHT GUARD FOR THE PAST 10 YEARS AND CONSTANTLY HAVE TO BUY ONE EVERY TWO YEARS. STILL LOOKING FOR A GOOD FITTING ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262419 NITE GUARD OBR RANIR LLC GEN III

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening