BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 24911724 · Received April 17, 2026

    Report

    Report Number
    3010457505-2026-00717
    Event Type
    Injury
    Date Received
    April 17, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 17, 2026
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983129
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE'S MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE TRANSDUCER ARRAYS 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).

    Description of Event or Problem · 0

    A 76-YEAR-OLD FEMALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) BEGAN OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2026, THE PATIENT REPORTED TO NOVOCURE THAT SHE HAD TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY DUE TO SEVERE ITCHING, WHICH WAS DESCRIBED AS INTENSE ENOUGH TO DISRUPT HER SLEEP. THE PATIENT REPORTED USING A SKIN PREPARATION PRODUCT AND TAKING UP TO 2000 MG PER DAY OF UNSPECIFIED ANTI-ITCHING MEDICATION. ON (B)(6) 2026, THE PATIENT CLARIFIED THAT SHE HAD BEEN PRESCRIBED ORAL HYDROXYZINE. THE PATIENT'S PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADDITIONAL INFORMATION AND RESPONDED ON (B)(6) 2026, STATING THAT THIS EVENT HAD NOT BEEN TREATED IN THEIR OFFICE AND THAT THE PATIENT CONTINUED OPTUNE LUA THERAPY. THE PHYSICIAN FURTHER INDICATED THAT THE PRESCRIPTION FOR HYDROXYZINE WAS LIKELY ISSUED BY ANOTHER HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488109 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983129

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention APIXABAN.| BUDESONIDE.| CARVEDILOL.| FORMOTEROL.| FUROSEMIDE.| IPRATROPIUM.| LIDOCAINE.| LOSARTAN.| METHOCARBAMOL.| ONDANSETRON.| POTASSIUM CHLORIDE.| PRILOCAINE.| SALBUTAMOL.