BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 3873771 · Received March 25, 2014

    Report

    Report Number
    1825660-2014-00861
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 24, 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 THE ROOT CAUSE (MALFUNCTION, DEVICE IS BEING USED FOR UNINTENDED USE, ETC.). NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A DEVICE LAMINATION IS A REPORTABLE MALFUNCTION. CHOKING IS POSSIBLE AS A RESULT OF THE DELAMINATION.

    Description of Event or Problem · 1

    HE FOLLOWED THE INSTRUCTIONS BUT AFTER A FEW WEEKS THE TOP SEPARATED FROM THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173534 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening