BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 23739983 · Received December 8, 2025

    Report

    Report Number
    3010457505-2025-00643
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    November 13, 2025
    Report Date
    January 8, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    UDI-DI
    07290107982207
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON DECEMBER 12, 2025, THE PRESCRIBING PHYSICIAN REPORTED THAT THE PATIENT DID NOT SUSTAIN ANY INJURIES AS A RESULT OF THE FALL AND WAS NOT HOSPITALIZED. OPTUNE GIO THERAPY HAD BEEN TEMPORARILY DISCONTINUED; HOWEVER, THERAPY HAD RESUMED AT THE TIME OF THE REPORT. ACCORDING TO THE PRESCRIBER, THE EVENT WAS NOT RELATED TO OPTUNE GIO THERAPY.

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAYS TO THE SKIN LACERATION CANNOT BE RULED OUT. THE FALL WAS UNRELATED TO DEVICE USE. SKIN LACERATION 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 51-YEAR-OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE GIO THERAPY ON (B)(6) 2023. ON (B)(6) 2025, THE PATIENT INFORMED NOVOCURE THAT ON THE PREVIOUS DAY SHE HAD FALLEN DOWN THE STAIRS WHILE ON OPTUNE GIO THERAPY AND SUSTAINED A SCALP LACERATION REQUIRING SUTURES. THE PATIENT TEMPORARILY DISCONTINUED OPTUNE GIO THERAPY. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER INFORMATION, ALTHOUGH NO REPLY WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2423266 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100 07290107982207

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention CLOBETASOL.| HYDROCHLOROTHIAZIDE.| LACOSAMIDE.| LEVETIRACETAM.| LISINOPRIL.| MIDAZOLAM.| SENNA GLYCOSIDE.