BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORAL APPLIANCE

    MDR report key: 4231648 · Received November 2, 2014

    Report

    Report Number
    MW5038955
    Event Type
    Injury
    Date Received
    November 2, 2014
    Date of Event
    October 5, 2014
    Report Date
    November 2, 2014
    Manufacturer
    AMERICAN SLEEP ASSOCIATION
    Product Code
    LRK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ORDERED AN ORAL DEVICE FROM (B)(6) TO CORRECT MILD APNEA AND SNORING. IT WAS MADE BY THEIR LABORATORY FROM IMPRESSIONS THAT MY DENTIST HELPED ME MAKE. WHEN THE MOUTHPIECE CAME, IT CONSISTED OF UPPER AND LOWER TRAYS HELD TOGETHER BY A VELCRO TYPE STRIP AND METAL DEVICES ON EACH SIDE. IN THE PROCESS OF WEARING THEM FOR INCREASING PERIODS DURING THE NIGHT, MY MOUTH, TONGUE, GUMS, LIPS, UPPER PALATE, AND BACK OF THROAT BECAME VERY RAW AND SORE. I WAS MISERABLE AND UNABLE TO EAT OTHER THAN VERY SOFT OR LIQUID FOODS. I DISCONTINUED USE OF THE ORAL DEVICE AND SUSPECTED AN ALLERGIC REACTION TO THE METAL, SPECIFICALLY NICKEL. I CALLED THEM TO FIND OUT IF NICKEL WAS A COMPONENT OF THE METAL USED. THEY DID NOT KNOW AND SAID IT WAS STAINLESS STEEL AND DID NOT KNOW IF IT WAS SURGICAL GRADE. I WAS NEVER ASKED ABOUT ANY ALLERGIES. (B)(6) SAID THAT I WAS ONE OF THE FIRST CLIENTS TO RECEIVE THE DEVICE WITH THE METAL COMPONENT SO THEY HAD NO PREVIOUS COMPLAINTS. PATIENT GUINEA PIGS; NO CLINICAL TRIALS? THEY ASKED ME TO SEND THE ORAL DEVICE BACK TO THEM WHICH I DID IMMEDIATELY ON (B)(6) 2014 AND HAVE NOT HEARD ANYTHING FROM THEM SINCE. I RECEIVED THE EOB AND THE ONLINE DEVICE COSTING (B)(6) WAS BILLED TO (B)(6) AND WAS PAID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700771 ORAL APPLIANCE ANTI SNORING DEVICE LRK AMERICAN SLEEP ASSOCIATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other