BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KATALYST TRAINING SYSTEM

    MDR report key: 20273954 · Received September 20, 2024

    Report

    Report Number
    3014545203-2024-00004
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 20, 2024
    Manufacturer
    KATALYST INTERACTIVE INC.
    Product Code
    NGX
    PMA / PMN Number
    K190966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MEMBER HAD A RUPTURED DISC IN MAY AND STATED THAT IT WAS POSSIBLY FROM KATALYST. THE DOCTOR INITIALLY RECOMMENDED A DISCECTOMY, BUT WE OPTED EPIDURAL INJECTIONS AND REST INSTEAD OF SOMETHING SO INVASIVE. I UNDERWENT EPIDURAL INJECTIONS IN MAY, JULY, AND AUGUST, WITH THE MOST RECENT ONE ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472470 KATALYST TRAINING SYSTEM Stimulator, muscle, powered, for muscle conditioning NGX KATALYST INTERACTIVE INC. KATALYST SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention