BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONICS OASIS

    MDR report key: 4541670 · Received February 20, 2015

    Report

    Report Number
    MW5040884
    Event Type
    Injury
    Date Received
    February 20, 2015
    Date of Event
    January 1, 2014
    Report Date
    February 20, 2015
    Manufacturer
    NEUROMONICS INC.
    Product Code
    KLW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT SHE WAS SUFFERING FROM TINNITUS IN HER RIGHT EAR. HER AUDIOLOGIST PRESCRIBED NEUROMONICS OASIS TO ALLEVIATE THE SYMPTOMS. THE REPORTER STATED THAT SHE SUFFERED FROM ADVERSE EFFECT USING THE DEVICE. SHE IS EXPERIENCING LOUD SCREECHING NOISES AND THE PITCH WAS VERY LOUD. AFTER WEARING THE DEVICE, BOTH OF HER EARS BECAME AFFECTED. THE REPORTER ALSO COMPLAINED THAT HER AUDIOLOGIST DID NOT GIVE HER A PRESCRIPTION FOR THE DEVICE. THE REPORTER STATED AS A RESULT FO THIS CONDITION, SHE HAS NOT BEEN ABLE TO FUNCTION NORMALLY FOR THE PAST THIRTEEN MONTHS. SHE HAS STOPPED WORKING, AND HAS NOT BEEN ABLE TO GO TO PUBLIC PLACES SINCE THE SURROUNDING NOISE IS TOO LOUD FOR HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122765 NEUROMONICS OASIS NEUROMONICS OASIS KLW NEUROMONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Disability