BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE PROTECTOR

    MDR report key: 4113721 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00824
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 11, 2014
    Report Date
    May 1, 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

    NO ADDITIONAL INFO 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

    THE FIRST NIGHT SHE FITTED THE GUARD, AFTER LESS THAN A WEEK IT STARTED TO PULL APART FROM THE HARD BASE. SHE FITTED THE 2ND ONE AND DIDN'T BITE DOWN AS HARD SO SHE LEFT MORE OF THE TOP AND BOTTOM TOGETHER, AND THAT ONE COMPLETELY CAME OFF THE SOFT TOP. SHE USED THAT ONE FOR ABOUT 4 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262411 NITE PROTECTOR MOUTHGUARD, OVER THE COUNTER OBR RANIR LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1