BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4128576 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00777
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    February 17, 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 EVENT HAPPENED IN (B)(6). 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

    HE USED THE NITE PROTECTOR FOR TWO WEEKS AND IT SPLIT AT ITS SEAMS. HE ASKED FOR A REPLACEMENT AND MORE INFORMATIVE INSTRUCTIONS ON ITS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263355 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR CORPORATION GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening