BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE LUA

    MDR report key: 21957965 · Received May 5, 2025

    Report

    Report Number
    3010457505-2025-00495
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 5, 2025
    Manufacturer
    NOVOCURE GMBH
    Product Code
    SDA
    UDI-DI
    07290107983235
    PMA / PMN Number
    P230042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE TRANSDUCER ARRAYS TO THE ALLERGIC REACTION CANNOT BE RULED OUT. A RISK FACTOR FOR HYPERSENSITIVITY IN THIS PATIENT INCLUDES CONCOMITANT DOCETAXEL (HYPERSENSITIVITY REACTIONS, AND OTHER DERMATOLOGICAL ISSUES SUCH AS RASHES, ERYTHEMA, AND SKIN TOXICITIES ARE LISTED AMONG THE MOST COMMON ADVERSE REACTIONS SOURCE: DOCETAXEL PRESCRIBING INFORMATION). HYPERSENSITIVITY WAS NOT REPORTED IN THE PIVOTAL EF-24 CLINICAL TRIAL FOR OPTUNE LUA TREATMENT FOR NSCLC. HYPERSENSITIVITY HAS BEEN REPORTED APPROXIMATELY 395 TIMES IN THE COMMERCIAL PROGRAM TO DATE, 9 OF WHICH WERE SERIOUS AND RELATED TO DEVICE USE.

    Description of Event or Problem · 0

    AN 80-YEAR-OLD MALE PATIENT WITH NON-SMALL CELL LUNG CANCER (NSCLC) STARTED OPTUNE LUA THERAPY ON (B)(6) 2025. ON (B)(6) 2025, NOVOCURE WAS INFORMED THAT THE PATIENT HAD TEMPORARILY DISCONTINUED OPTUNE LUA THERAPY ON (B)(6) 2025, DUE TO THE DEVELOPMENT OF A RASH AFFECTING THE UPPER BODY, INCLUDING BOTH THE BACK AND FRONT. THE HEALTHCARE PROVIDER (HCP) PRESCRIBED UNSPECIFIED MEDICATIONS, INCLUDING AN ANTIBIOTIC, TO TREAT THE RASH. THE PROVIDED IMAGE DEMONSTRATED AREAS OF MILD ERYTHEMA ON THE RIGHT TORSO. ON (B)(6) 2025, THE PATIENT REPORTED THAT HE STILL EXPERIENCED ITCHING AND REMAINED OFF THERAPY. IN ADDITION, HE WAS EVALUATED BY A DERMATOLOGIST ON (B)(6) 2025, WHO DETERMINED THAT THE RASH WAS AN ALLERGIC REACTION TO THE ADHESIVE USED ON THE ARRAYS. ON (B)(6) 2025, IT WAS REPORTED THAT THE PRESCRIBING PHYSICIAN RECOMMENDED THE USE OF A SKIN BARRIER FILM AND TOPICAL CORTICOSTEROIDS. ADDITIONALLY, FOLLOWING THE DERMATOLOGIST'S CONSULTATION, ORAL CORTICOSTEROIDS WERE PRESCRIBED. ATTEMPTS TO CONTACT THE PRESCRIBING PHYSICIAN FOR FURTHER DETAILS WERE MADE, ALTHOUGH NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444113 OPTUNE LUA OPTUNE LUA SDA NOVOCURE GMBH TFT9200 07290107983235

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention ACETYLSALICYLIC ACID.| ALBUTEROL.| ATORVASTATIN.| BENZONATATE.| BUDESONIDE-FORMOTEROL.| CYCLOBENZAPRINE.| DESONIDE TOPICAL OINTMENT.| DEXAMETHASONE.| DOCETAXEL.| DORZOLAMIDE-TIMOLOL.| FEXOFENADINE.| FUROSEMIDE.| LATANOPROST.| LEVOTHYROXINE.| METFORMIN.| METOPROLOL SUCCINATE.| METRONIDAZOLE.| OMEPRAZOLE.| ONDANSETRON.| SPIRONOLACTONE.| TAMSULOSIN.| TRIAMCINOLONE ACETONIDE TOPICAL OINTMENT.| VALSARTAN.