BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20832328 · Received December 3, 2024

    Report

    Report Number
    3010457505-2024-00390
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    November 7, 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
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE WOUND DEHISCENCE CANNOT BE RULED OUT. WOUND DEHISCENCE 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 62-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2019. ON (B)(6) 2024, THE PATIENT INFORMED NOVOCURE THAT THROUGHOUT THE COURSE OF OPTUNE GIO THERAPY, HE HAD EXPERIENCED ISSUES WITH HIS SURGICAL RESECTION SITE SCAR (LAST SURGICAL RESECTION (B)(6) 2018) OPENING AND BECOMING IRRITATED. OCCASIONALLY, THE PATIENT'S SPOUSE APPLIED AN OINTMENT WITH NEOMYCIN/POLYMYXIN B/BACITRACIN, BUT WITH LIMITED SUCCESS. RECENTLY, THE PATIENT PLACED AN ADHESIVE BANDAGE OVER THE OPEN WOUND BEFORE OPTUNE GIO TRANSDUCER ARRAY APPLICATION, WHICH HELPED. THE PATIENT WAS INSTRUCTED TO NOT PLACE OPTUNE GIO ARRAY DISCS DIRECTLY OVER THE ADHESIVE BANDAGE. ON (B)(6) 2024, THE PATIENT'S HEALTHCARE PROVIDER (HCP) INFORMED NOVOCURE THAT THE EVENT HAS BEEN INTERMITTENTLY PRESENT SINCE SURGERY. PER THE HCP, THE EVENTS WERE NOT RELATED TO OPTUNE GIO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544152 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention ACETYLCYSTEINE.| ALPRAZOLAM.| ASCORBIC ACID.| CANNABIS OIL.| CYANOCOBALAMIN.| IODINE.| IVERMECTIN.| LEVETIRACETAM.| LIDOCAINE.| SERENOA REPENS SUPPLEMENT.| TAMSULOSIN.| TURMERIC.| VITAMIN D3.