BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2592136 · Received May 24, 2012

    Report

    Report Number
    1723686-2012-00009
    Event Type
    Other
    Date Received
    May 24, 2012
    Date of Event
    May 9, 2012
    Report Date
    May 24, 2012
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PATIENT STATES THAT HE RECEIVED BURNS AND BLISTERS TO THE SKIN THE SIZE OF THE ELECTRODES. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(6) 2012 WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE TENS, HMD; TIMER: 90 MIN., DATA: 4516 MINS,; 115 TIMES. UNIT TESTED BY JOE MOORE, MANUFACTURING TECHNICIAN, ON (B)(6) 2012. HE TESTED THE UNIT AS RECEIVED FROM THE PATIENT. HE FOUND THAT THE UNIT PASSED ALL TESTS, NO PROBLEM COULD BE FOUND WITH THE UNIT. THE ELECTRODES WERE NOT RETURNED WITH THE UNIT. CONCLUSION: WE COULD NOT CONFIRM THE PROBLEM DESCRIBED BY THE PATIENT.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE RECEIVED BURNS ON HIS FOOT THE SAME SIZE OF THE ELECTRODES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other