BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2997559 · Received March 4, 2013

    Report

    Report Number
    1723686-2013-00002
    Event Type
    Other
    Date Received
    March 4, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 1, 2013
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    KPI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT TREATED AREA WITH PAIN RELIEF CREAM. DID NOT SEEK PROFESSIONAL MEDICAL TREATMENT.

    Description of Event or Problem · 1

    PATIENT REPORTED SHE HAD A BURNING SENSATION WHEN USING THE DEVICE AT 23MA SETTING. COULD NOT FEEL THE STIMULATION AT LOWER SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91478 ZYNEX ELECTRICAL CONTINENCE DEVICE KPI ZYNEX MEDICAL, INC. INWAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other