BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 3987639 · Received June 10, 2014

    Report

    Report Number
    1825660-2014-00851
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 5, 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 MFR, AND NO LOT NUMBER INFO WAS GIVEN SO AN EVAL CANNOT BE PERFORMED AS TO THE ROOT CAUSE OF 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

    SHE FOLLOWED THE DIRECTIONS WITH BOTH BUT THE 2 PIECES KEPT SEPARATING AND BECAME UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340312 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening