BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZYNEX

    MDR report key: 2593977 · Received May 23, 2012

    Report

    Report Number
    1723686-2012-00008
    Event Type
    Other
    Date Received
    May 23, 2012
    Date of Event
    April 23, 2012
    Report Date
    May 23, 2012
    Manufacturer
    ZYNEX MEDICAL INC.
    Product Code
    GZJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PATIENT STATES THAT THEY RECEIVED AN ADVERSE REACTION TO THE SKIN WHERE THE ELECTRODES WERE PLACED. DHR REVIEW REVEALED THAT THE UNIT WAS MANUFACTURED BY ZYNEX ON (B)(4) 2012, WITH NO ISSUES. UNIT PASSED ZYNEX FINAL TESTING WITH NO ISSUES. MODE TENS, HMD; TIMER: 60 MIN., DATA: 833 MINS,; 14 TIMES. UNIT TESTED BY (B)(6), MANUFACTURING TECHNICIAN, ON (B)(4) 2012. HE TESTED THE UNIT AS RECEIVED FROM THE SALES REPRESENTATIVE WITH THE LEAD WIRES RETURNED WITH THE UNIT. HE FOUND THAT THE UNIT PASSED ALL TESTS, NO PROBLEM COULD BE FOUND WITH THE UNIT, OTHER THAN THE CRACK IN THE LCD WHICH HINDERED SOME OF THE CHARACTERS ON THE DISPLAY. THE ELECTRODES WERE NOT RETURNED WITH THE UNIT. CONCLUSION: WE COULD NOT CONFIRM THE PROBLEM DESCRIBED BY THE PATIENT. CORRECTIVE ACTION: NONE REQUIRED. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE RECEIVED 2 BURNS ON HER BACK WHERE THE ELECTRODES WERE PLACED.

    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