BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IOMAX BASE MODULE

    MDR report key: 21334114 · Received February 6, 2025

    Report

    Report Number
    MW5165773
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 22, 2025
    Report Date
    February 3, 2025
    Manufacturer
    CADWELL INDUSTRIES, INC.
    Product Code
    GWF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BURNS TO UPPER EXTREMITY AND BILATERAL LOWER EXTREMITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835623 IOMAX BASE MODULE STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF CADWELL INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown