BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19926729 · Received August 7, 2024

    Report

    Report Number
    3010457505-2024-00313
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 7, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE TRANSDUCER ARRAY PLACEMENT TO THE SKIN ULCER CANNOT BE RULED OUT. CONTRIBUTING FACTORS FOR SKIN ULCER IN THIS PATIENT INCLUDE PRIOR RADIATION, CHEMOTHERAPY, AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. MEDICAL DEVICE SITE ULCER IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 1% AND <1% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 76-YEAR-OLD MALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2019. NOVOCURE WAS INFORMED ON MAY 23, 2024, THAT THE PATIENT EXPERIENCED A SKIN REACTION DESCRIBED AS PAINFUL BLISTERS ON THE SCALP. OPTUNE GIO WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, THE PATIENT NOTED HE RESUMED OPTUNE GIO THERAPY AND WAS CHANGING THE ARRAYS DAILY. THE PRESCRIBING PHYSICIAN INFORMED NOVOCURE ON JULY 17, 2024, THAT THE PATIENT DEVELOPED A SIGNIFICANT ULCERATION/MOIST DESQUAMATION OVER HIS LEFT FRONTAL CRANIOTOMY SCAR. THE PHYSICIAN WAS CONCERNED ABOUT POSSIBLE WOUND BREAKDOWN AND SUBSEQUENT NEED FOR RECONSTRUCTIVE SURGERY. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579741 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Other BIMATOPROST| CICLOPIROX| DORZOLAMIDE-TIMOLOL| FENOFIBRATE| LEVETIRACETAM| LISINOPRIL| LORAZEPAM| METFORMIN| ONDANSETRON| PREDNISOLONE ACETATE| TAMSULOSIN