BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 19891860 · Received August 2, 2024

    Report

    Report Number
    3010457505-2024-00312
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 5, 2024
    Report Date
    August 2, 2024
    Manufacturer
    NOVOCURE, INC.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE SKIN INFLAMMATION/IRRITATION CANNOT BE RULED OUT. MEDICAL DEVICE SITE REACTION IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 16% AND 53% EF-14 OPTUNE ARM). ADDITIONAL NOTE: MANUFACTURING DATE OF (B)(6) IS MAY 28, 2024.

    Description of Event or Problem · 0

    A 65-YEAR-OLD FEMALE WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. NOVOCURE WAS INFORMED ON JUNE 04, 2024, THAT THE PATIENT EXPERIENCED A SKIN REACTION DESCRIBED AS A RASH AND OPEN AREAS ON THE SCALP. THE PATIENT WAS SEEN BY A DERMATOLOGIST THAT PRESCRIBED A CORTISONE OINTMENT TO APPLY TO THE SCALP TWICE DAILY. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2024, REPORTEDLY, THE SKIN REACTION HAD RETURNED, AND THE PREVIOUSLY AFFECTED AREAS HAD NOT HEALED BEFORE SHE REAPPLIED THE ARRAYS. ON (B)(6) 2024, IT WAS NOTED THE PATIENT AGAIN CONSULTED A DERMATOLOGIST AS SHE EXPERIENCED SEVERE ITCHING AND BURNING UNDER THE ARRAYS. TREATMENT INCLUDED AN ORAL ANTIBIOTIC (TRIMETHOPRIM/SULFAMETHOXAZOLE) AND A CORTISONE CONTAINING TOPICAL MEDICATION. THE PATIENT REPORTED ON (B)(6) 2024, THAT OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED SINCE (B)(6) 2024, DUE TO SKIN IRRITATION WITH BLISTERS THAT DEVELOPED UNDER THE ARRAYS. THE PRESCRIBING PHYSICIAN REPORTED ON JULY 31, 2024, THAT THE PATIENT WAS TREATED WITH A TOPICAL OINTMENT AND ASSESSED THE EVENT AS RELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740163 OPTUNE GIO OPTUNE GIO NZK NOVOCURE, INC. TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other ALIZAPRIDE.| TEMOZOLOMIDE.