BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILENT NIGHT SL

    MDR report key: 3961029 · Received July 22, 2014

    Report

    Report Number
    MW5037431
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    GLIDEWELL LABORATORIES
    Product Code
    NIL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING A GLIDEWELL LABORATORIES SILENT NITE SL MOUTH APPLIANCE TO TREAT MY SLEEP APNEA CONDITION. I HAVE BEEN USING THE DEVICE FOR OVER 2 YEARS. DURING THIS TIME I HAVE DEVELOPED TINNITUS. THE TINNITUS CAN BE GREATLY REDUCED WHEN I ADJUST MY JAW BY MOVING MY JAW IN THE OPPOSITE DIRECTION OF WHAT THE SILENT NITE SL DOES. I HAVE ALSO BEEN DIAGNOSED WITH THE ONSET OF OSTEOARTHRITIS IN THE RIGHT TMJ REGION. I HAVE ALSO NOTICED THAT MY BITE HAS PERMANENTLY CHANGED POSITION FROM WHAT IT USED TO BE. THIS HAS RESULTED IN A "QUALITY OF LIFE" ISSUE THAT HAS BECOME ANNOYING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429085 SILENT NIGHT SL NONE NIL GLIDEWELL LABORATORIES SILENT NIGHT SL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other