BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE PROTECTOR

    MDR report key: 3922125 · Received June 2, 2014

    Report

    Report Number
    1825660-2014-00841
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 2, 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

    NO ADDITIONAL INFORMATION IS GIVEN BY THE CONSUMER. NO LOT CODE WAS GIVEN, NO PRODUCT WAS RETURNED FOR INVESTIGATION. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS SOUGHT. THIS IS BEING REPORTED BECAUSE IF PART OF THE DEVICE IS SWALLOWED DUE TO DELAMINATION, MEDICAL ATTENTION MAY BE NECESSARY TO REMOVE THE DEVICE.

    Description of Event or Problem · 1

    NO PROBLEM WITH THE FITTING REALLY BUT THE PROTECTOR FELL APART AT THE SEAMS, EVENTUALLY SEPARATING INTO 2 PIECES. THE BLUE SECTION SEPARATED COMPLETELY FROM THE WHITE SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322042 NITE PROTECTOR MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN III

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening