BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONICS OASIS

    MDR report key: 1696485 · Received May 16, 2010

    Report

    Report Number
    MW5016031
    Event Type
    Injury
    Date Received
    May 16, 2010
    Date of Event
    May 2, 2008
    Report Date
    May 16, 2010
    Manufacturer
    NEUROMONICS
    Product Code
    KLW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEUROMONICS OASIS: IS A DEVICE THAT CLAIMS TO TREAT THE HORRIBLE EFFECTS OF TINNITUS -CHRONIC RINGING IN THE EARS-. IT IS EXPENSIVE AND HAS NOT BEEN TESTED. IT'S ESSENTIALLY LIKE A (B) (4) WITH SPECIAL MUSIC FROM THEIR RESEARCH AND THEY WANT IT USED FOR AT LEAST A FEW MONTHS. I STARTED USING THIS DEVICE -THEY ESSENTIALLY CLAIM IT TRAINS THE BRAIN NOT TO HEAR THE RINGING- AND AFTER LESS THAN TWO WEEKS MY TINNITUS -WHICH WAS HORRIBLE TO BEGIN WITH- BECAME MUCH, MUCH WORSE AND HAS REMAINED SO SINCE THEN. THEY REFUNDED MY MONEY BUT THE INCREASED TINNITUS HAS MADE MY EVERYDAY LIFE MISERABLE. I BEGAN AN INTERNET WEBSITE (B) (6) AND HAVE RECEIVED MANY SIMILAR COMPLAINTS (B) (6). THANK YOU. (B) (6). DATES OF USE: (B) (6) 2008 -- (B) (6) 2008. DIAGNOSIS OR REASON FOR USE: TINNITUS TREATMENT. EVENT ABATED AFTER USE: NO. THIS IS A VERY DANGEROUS DEVICE... AND IS BEING MARKETED TO THOSE WHO SUFFER FROM THE TERRIBLE EFFECTS -PHYSICAL AND EMOTIONAL- OF TINNITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONICS OASIS NEUROMONICS OASIS KLW NEUROMONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| O