BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2507493 · Received March 15, 2012

    Report

    Report Number
    1723686-2012-00004
    Event Type
    Other
    Date Received
    March 15, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 14, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    IPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT FELL ASLEEP WITH THE UNIT ON. CONCLUSION: THE SMALL SOLDER BRIDGE LIKELY CAUSED AN INTERMITTENT FAILURE THAT GAVE CHANNEL TWO A SURGE OF OUTPUT CURRENT AND THIS COULD HAVE CAUSED THE BURNS ON THE SKIN.

    Description of Event or Problem · 1

    PT REPORTED THAT SHE RECEIVED 4 BURN MARKS ON HER KNEE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other