BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4113806 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00076
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    January 29, 2013
    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 MANUFACTURER. 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

    COST: (B)(6) PLUS TAX - NO RECEIPT AVAILABLE. UPC PLUS LOT # ENCLOSED. UPPER LAYER SEPARATED FROM HARD BASE AFTER 6 NIGHTS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262597 NITE GUARD OBR RANIR, LLC GEN II ORIG

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening