BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNORE GUARD

    MDR report key: 4128621 · Received May 1, 2014

    Report

    Report Number
    1825660-2014-00802
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    January 28, 2014
    Report Date
    April 30, 2014
    Manufacturer
    RANIR CORPORATION
    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 REPORT IS FROM (B)(4). THIS COMPLAINT HAS NOT BEEN CONFIRMED. THE DEVICE NOT RETURNED TO MANUFACTURER, AND NO LOT NUMBER INFORMATION WAS GIVEN SO AN EVALUATION CANNOT BE PERFORMED AS TO THE ROOT CAUSE OR ACTUAL NATURE OF THE PROBLEM. NO INJURY WAS REPORTED, NO MEDICAL ATTENTION WAS REPORTED TO HAVE BEEN SOUGHT. THIS IS BEING REPORTED AS A POSSIBLE CHOKING HAZARD.

    Description of Event or Problem · 1

    THE BLUE SNORE GUARD MATERIAL IS SEPARATING FROM THE WHITE MOUTH GUARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263418 SNORE GUARD ANTI-SNORING DEVICE LRK RANIR CORPORATION SNORE GUARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening