BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19946747 · Received August 9, 2024

    Report

    Report Number
    3010457505-2024-00314
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 9, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE PLACEMENT OF THE TRANSDUCER ARRAYS TO THE WOUND INFECTION CANNOT BE RULED OUT. WOUND INFECTION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF- 11 0% AND <1% EF-14 OPTUNE ARM). ADDITIONAL NOTE: MANUFACTURING DATE OF (B)(6) IS SEPTEMBER 07, 2020.

    Description of Event or Problem · 0

    A 75-YEAR- OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. ON (B)(6) 2024, NOVOCURE WAS INFORMED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A FEVER AND INFECTION OF THE SURGICAL RESECTION SITE. THE PHYSICIAN ASSESSED THIS EVENT AS SERIOUS AND UNRELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702900 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| O NOT PROVIDED.