BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 1994419 · Received February 9, 2011

    Report

    Report Number
    1723686-2011-00002
    Event Type
    Other
    Date Received
    February 9, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 9, 2011
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ALTHOUGH THE POPPING SENSATION WAS NOT AS NOTICEABLE ON CERTAIN INDIVIDUALS, IT COULD BE FELT BY 75% OF THOSE TESTED INTERNALLY AT ZYNEX. THE CONSENSUS WAS THAT IT COULD BE PERCEIVED AS AN UNPLEASANT SHOCK TO CERTAIN INDIVIDUALS MORE SENSITIVE TO ELECTRICAL STIMULATION AND WARRANTED CORRECTION.

    Description of Event or Problem · 1

    PATIENT REPORTED HE GOT A SHOCK WHEN USING THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other