BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20829393 · Received December 3, 2024

    Report

    Report Number
    3010457505-2024-00380
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    October 21, 2024
    Report Date
    December 3, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE CONTACT DERMATITIS CANNOT BE RULED OUT. DERMATITIS CONTACT IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND 1% EF-14 OPTUNE ARM).

    Description of Event or Problem · 0

    A 74-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2024, NOVOCURE RECEIVED PATIENT'S MEDICAL RECORDS REGARDING A FOLLOW-UP VISIT WITH THE PATIENT'S PHYSICIAN ON (B)(6) 2024. THE PATIENT REPORTEDLY EXPERIENCED INCREASED CONTACT DERMATITIS WITH SKIN BREAKDOWN IN THE AREAS OF THE OPTUNE GIO ARRAYS. HE TRIED ALTERNATING ARRAY PLACEMENT 2CM FORWARDS/BACKWARDS/SIDEWAYS, BUT STILL ENCOUNTERED IRRITATION. THE PHYSICIAN RECOMMENDED TO TEMPORARILY DISCONTINUE OPTUNE GIO THERAPY FOR FIVE DAYS AS THIS HAD HELPED IN THE PAST. HE PRESCRIBED TRIAMCINOLONE LOTION AND PERORAL HYDROXYZINE FOR USE AT NIGHT AS NEEDED FOR ITCHING. INSTRUCTIONS WERE GIVEN TO USE A BARRIER CREAM AT NIGHT. ON (B)(6) 2024, THE PATIENT'S PHYSICIAN CONFIRMED THAT THE PATIENT WAS PRESCRIBED HYDROXYZINE AND TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY. THE PATIENT HAD SINCE RESUMED OPTUNE GIO THERAPY. THE PHYSICIAN ASSESSED THE EVENTS AS MORE LIKELY OPTUNE GIO RELATED THAN OTHER CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209754 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention ACETYLSALICYLIC ACID.| AZELASTINE.| DIAZEPAM.| FAMOTIDINE.| FLUTICASONE PROPIONATE.| GABAPENTIN.| MULTIVITAMIN.| SENNOSIDE.