BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNORE GUARD RETAIL

    MDR report key: 3994089 · Received July 24, 2014

    Report

    Report Number
    1825660-2014-00876
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    RANIR, LLC
    Product Code
    LRK
    PMA / PMN Number
    K103004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THIS COMPLAINT HAS NOT BEEN CONFIRMED. NO ADD'L INFO IS GIVEN BY THE CONSUMER. NO LOT CODE WAS GIVEN AND THE DEVICE WAS NOT RETURNED TO MANUFACTURER, SO AN EVAL CANNOT BE PERFORMED AS TO THE ROOT CAUSE. THERE IS NO SERIOUS INJURY AND NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS INCIDENT IS BEING REPORTED AS A SEPARATION TYPE OF MALFUNCTION THAT COULD POSSIBLY LEAD TO SERIOUS INJURY. THE CONSUMER CANNOT CHOKE ON THE DEVICE BECAUSE THE CONFIGURATION OF THE MATERIAL WILL NOT LEAD TO SEALING OFF THE AIRWAYS. HOWEVER, IF A SEPARATED PART OF THE DEVICE PASSES BEYOND THE PHARYNGEAL ARCH, MEDICAL INTERVENTION MAY BE NECESSARY TO RETRIEVE THE MATERIAL.

    Description of Event or Problem · 1

    PUSHED BOTTOM TEETH TOO FAR IN AND MY TOOTH IS HITTING IT WHITE PLASTIC FRAME. LOVE YOUR PRODUCT. BEEN USING 1-1/2 YRS. BUT ONLY LASTING 3 MONTHS AS BOTTOM BLUE COMES DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433841 SNORE GUARD RETAIL ANTI-SNORING DEVICE LRK RANIR, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening