BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2181504 · Received July 12, 2011

    Report

    Report Number
    1723686-2011-00005
    Event Type
    Other
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 12, 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: COULD NOT DUPLICATE THE PROBLEM SEEN BY THE CUSTOMER, LIKELY THE INCREASED STIM WAS DUE TO THE MODE IT WAS IN.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE HAS A BURN ON THE BACK OF HER NECK USING THE TENS DEVICE.

    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