BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONA PILLOW

    MDR report key: 850625 · Received May 4, 2007

    Report

    Report Number
    MW1042805
    Event Type
    Other
    Date Received
    May 4, 2007
    Date of Event
    May 3, 2007
    Report Date
    May 4, 2007
    Manufacturer
    SLEEP DEVICES, INC.
    Product Code
    MYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PURCHASED SONA PILLOW -FDA #K040161-AND USED ACCORDING TO INSTRUCTIONS. RESULTED IN DISABLING NECK PAIN. WANTED TO RETURN THE "MEDICAL DEVICE" AND WAS TOLD BY COMPANY -SLEEP DEVICES INC.- IT WAS NOT RETURNABLE DUE TO FDA REGULATIONS.** I RESEARCHED THE FDA APPROVAL OF THIS "DEVICE" AND FOUND IT WAS APPROVED "UNDER 872.557, INTRAORAL DEVICES FOR SNORING AND OBSTRUCTIVE SLEEP APNEA." PLEASE NOTE, THIS IS NOT AN INTRAORAL DEVICE - IT IS A PILLOW THAT YOU PLACE YOUR HEAD ON DURING SLEEP. **QUOTE FROM WWW.SONAPILLOW.COM "RETURNS/POLICIES FEDERAL LAWS ON RETURNING BEDDING PRODUCTS ARE SIMILAR TO THE LAWS GOVERNING THE RETURN OF UNDERWEAR. FURTHERMORE, THE SONA PILLOW IS A PERSONAL MEDICAL DEVICE. USED MEDICAL EQUIPMENT CANNOT BE RETURNED, UNLESS THERE IS A MFG DEFECT IN THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONA PILLOW SONA PILLOW MYB SLEEP DEVICES, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other