BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KATALYST TRAINING SYSTEM

    MDR report key: 19112112 · Received April 15, 2024

    Report

    Report Number
    3014545203-2024-00002
    Event Type
    Injury
    Date Received
    April 15, 2024
    Date of Event
    March 16, 2024
    Report Date
    April 15, 2024
    Manufacturer
    KATALYST INTERACTIVE INC.
    Product Code
    NGX
    PMA / PMN Number
    K190966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    MEMBER REPORTED GETTING RHABDOMYOLYSIS AFTER USING KATALYST SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683117 KATALYST TRAINING SYSTEM Stimulator, muscle, powered, for muscle conditioning NGX KATALYST INTERACTIVE INC. 1064-01-A03 KVAA0100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| O SKU 1065-01-A03 LOT KSAA0103| SKU 1066-01-A03 LOT KAAA0103| SKU 1156-01-D00 LOT SIAB2803