BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 1617361 · Received February 24, 2010

    Report

    Report Number
    1723686-2010-00005
    Event Type
    Other
    Date Received
    February 24, 2010
    Date of Event
    January 25, 2010
    Report Date
    February 24, 2010
    Manufacturer
    ZYNEX MEDICAL INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE UNIT IS SHOCKING HER. CHANGED ELECTRODES AND LEAD WIRES BUT THE UNIT STILL SHOCKS HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX TENS ELECTRICAL STIMULATOR IPF ZYNEX MEDICAL INC. TRUWAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other