BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROMONICS OASIS TINNITUS DEVICE

    MDR report key: 4939120 · Received July 17, 2015

    Report

    Report Number
    MW5044715
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    May 26, 2015
    Report Date
    July 13, 2015
    Manufacturer
    NEUROMONICS INC
    Product Code
    KLW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NEUROMONICS OASIS TINNITUS DEVICE CAUSING BILATERAL INNER-EAR PRESSURE AND WORSENING TINNITUS, AS WELL AS WORSENING HYPOACUSIS. DEVICE OF NO BENEFIT AND APPEARS TO BE CAUSING HARM. WORSENING HYPERACUSIS AND TINNITUS WITH USE OF NEUROMONICS OASIS TINNITUS TREATMENT DEVICE. ALSO CAUSING SEVERE INNER EAR PRESSURE BILATERAL. NOT EFFECTIVE, OF NO BENEFIT, AND CAUSING HARM. DOSE, FREQUENCY AND ROUTE USED: DAILY 10 MIN TO 2 HRS. BILATERAL EARS LISTENING. THERAPY DATES: DAILY SINCE (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465891 NEUROMONICS OASIS TINNITUS DEVICE OASIS KLW NEUROMONICS INC OID-00000620

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other