BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113845 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00181
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2012
    Report Date
    April 29, 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. NO INJURY WAS REPORTED, NO MED 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

    I GOT IT TO FIT, BUT WITHIN 2 WEEKS THE PROTECTOR SEPARATED (BROKE APART), THE HEAVIER BOTTOM PEELING AWAY! I ALMOST CHOKED. PLEASE REPLACE! THE PRODUCT FELL APART. TOP LAYER BROKE AWAY FROM BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262496 NITE GUARD OBR RANIR LLC GEN II ORIG LOT: 426891

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening