BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITE GUARD

    MDR report key: 4114789 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00305
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    August 20, 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 MFR. 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

    THANKS FOR TAKING THE TIME TO SPEAK TO ME TODAY. AS DISCUSSED, THE DENTAL PROTECTOR THAT I PURCHASED WAS AT (B)(6). THE UPC CODE IS (B)(4); THE LOT # IS 041209. I WILL FORWARD A COPY OF THE RECEIPT TOMORROW. MANY THANKS FOR YOUR HELP. KIND REGARDS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262537 NITE GUARD MOUTHGUARD, OVER THE COUNTER OBR RANIR, LLC GEN II ORIG 041209

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening