BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2616647 · Received June 8, 2012

    Report

    Report Number
    1723686-2012-00011
    Event Type
    Other
    Date Received
    June 8, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 8, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DAMAGED GREY LEAD WIRE WAS LIKELY THE CAUSE OF THE SHOCK THAT THE PT EXPERIENCED. UNK HOW OR WHEN THE DAMAGE OCCURRED TO THE WIRE.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE RECEIVED A SHOCK FROM THE UNIT AND SHE HAD A RED MARK/SCAR THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYNEX INTERFERENTIAL ELECTRICAL STIMULATOR GZJ ZYNEX MEDICAL, INC. IF8100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other