BEUDAMED
    FDA Adverse Event Other Summary report: N

    SNORERX PLUS

    MDR report key: 3761531 · Received April 16, 2014

    Report

    Report Number
    MW5035708
    Event Type
    Other
    Date Received
    April 16, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    APNEA SCIENCES CORPORATION
    Product Code
    LRK
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I ORDERED A SNORERX MOUTHPIECE FROM THEIR WEBSITE: HTTP://WW.SNORERX.COM/INDEX.PHP. WHEN I RECEIVED IT AND READ THE ENCLOSED BROCHURE, I SAW IT IS CONTRAINDICATED FOR PEOPLE WHO HAVE HAD DENTAL IMPLANTS IN THE LAST YEAR, WHICH I HAVE HAD. THAT INFO IS NOT ON THE WEBSITE. ALSO, AND WHAT I THINK WILL BE MORE IMPORTANT TO THE FDA, THE BROCHURE CONTAINS THE FOLLOWING STATEMENT: "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY, OR ON THE ORDER OF, A PHYSICIAN." AS YOU CAN SEE FROM THE WEBSITE, ANYONE CAN ORDER THE DEVICE WITHOUT A PRESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232428 SNORERX PLUS SNORERX PLUS LRK APNEA SCIENCES CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR