BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOMNOGUARD AP2

    MDR report key: 6721376 · Received July 14, 2017

    Report

    Report Number
    MW5071044
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    July 7, 2017
    Report Date
    July 14, 2017
    Manufacturer
    TOMED GMBH
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LAST FRIDAY I WAS FITTED FOR A SLEEP APNEA MOUTH PIECE CALLED SOMNOGUARD AP2 AND OVER TIME REALIZED THAT MY AIR INTAKE THROUGH THE DEVICE WAS IMPAIRED DUE TO THE LATERAL IMMOBILIZATION BAR IN THE FRONT OF THE DEVICE. ADDITIONALLY THE BACK PORTION OF THE DEVICE BEGAN TO DETACH FROM MY UPPER MAXILLARY TEETH. IN ADDITION TO THIS THE DEVICE IS RELEASING A CHEMICAL THAT IS COATING MY ENTIRE MOUTH. I TRIED WASHING IT BUT IT KEPT RELEASING A CHEMICAL LEACHABLE/EXTRACTABLE. AFTER TWO NIGHTS OF CONTINUOUS SLEEP LOSS, I DISCONTINUED USAGE. MY DOCTOR DR (B)(6) REFUSES TO RESPOND DESPITE NUMEROUS ATTEMPTS TO CONTACT HIM. MY INSURANCE WILL ONLY COVER ONE DEVICE EVERY 3 YEARS AND I AM CONCERNED THAT I WILL BE STUCK WITH THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493858 SOMNOGUARD AP2 ANTI-SNORING DEVICE LRK TOMED GMBH AP2.0402.US.17

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other