BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXWAVE

    MDR report key: 24211764 · Received January 29, 2026

    Report

    Report Number
    3000214920-2026-00004
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    January 1, 2024
    Report Date
    January 29, 2026
    Manufacturer
    ZYNEX MEDICAL, INC.
    Product Code
    LIH
    UDI-DI
    00852670007007
    PMA / PMN Number
    K111279
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL INCIDENT OCCURRED IN EARLY 2024, BUT THE PATIENT DID NOT MAKE AN INITIAL REPORT TO ZYNEX MEDICAL, INC. AFTER THE INCIDENT, THE PATIENT DISPOSED OF THE DEVICE AND DIDN'T REVEAL HE HAD AN ISSUE UNTIL HE CALLED ZYNEX MEDICAL, INC., ON (B)(6) 2026, TO DISCUSS THE COMPANY FILING CHAPTER 11 BANKRUPTCY. AT THAT TIME, A COMPLAINT WAS INITIATED.

    Description of Event or Problem · 0

    THE PATIENT CALLED ZYNEX MEDICAL, INC. TO DISCUSS THE CHAPTER 11 FILING ON (B)(6) 2026, AND WHEN ASKED HOW THE NEXWAVE DEVICE IS WORKING, HE STATED THAT HE HASN'T USED IT SINCE EARLY 2024. THE PATIENT THEN STATED THAT DURING USE OF THE DEVICE, IN 2024, HE HAD AN ADVERSE REACTION TO THE STIMULATION, AND HE FELL BACK AND HIT HIS HEAD. THE PATIENT WENT TO THE HOSPITAL FOR CARE BUT DID NOT STATE THE LEVEL OF CARE RECEIVED. THE PATIENT HAD BEEN USING THE DEVICE A COUPLE WEEKS BUT DOES NOT RECALL HOW HE WAS TREATING HIMSELF AT THE TIME OF THE INCIDENT. THE PATIENT DISPOSED OF THE DEVICE AND DID NOT CALL ZYNEX MEDICAL TO REPORT THE ISSUE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272231 NEXWAVE NEXWAVE LIH ZYNEX MEDICAL, INC. 700400 1330318 00852670007007

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other