BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONA PILLOW

    MDR report key: 868225 · Received June 18, 2007

    Report

    Report Number
    MW5002694
    Event Type
    Other
    Date Received
    June 18, 2007
    Date of Event
    June 11, 2007
    Report Date
    June 18, 2007
    Manufacturer
    SLEEP DEVICES, INC.
    Product Code
    MYB
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MFR SAYS ON THEIR WEB SITE "STOPS SNORING & MILD SLEEP APNEA" AND I BOUGHT THE SONA PILLOW BASED ON THAT CLAIM. FOR ME, IT DOES NEITHER ONE, AND IT DISLOCATED MY NECK. THEIR FDA ALLOWED CLAIMS - K040161 - ARE: "MAY STOP OR DECREASE SNORING.", MAY BE USED TO TREAT MILD OBSTRUCTIVE SLEEP APNEA.", "MAY IMPROVE THE QUALITY OF SLEEP." MFR CLAIMS SONA PILLOW ABSOLUTELY "STOPS SNORING & MILD SLEEP APNEA". THIS IS BOTH FALSE AND MISLEADING. WITH A "NO RETURN" POLICY, MFR IS RIPPING OFF CONSUMERS. I AM CURRENTLY TRYING TO GET A CREDIT BACK THROUGH MASTERCARD AND AM RETURNING THE SONA PILLOW TO SLEEP DEVICES TODAY. DATES OF USE: 1HR; 2007. DIAGNOSIS: SNORING, SLEEP APNEA. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONA PILLOW NONE MYB SLEEP DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 YR