BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE GIO

    MDR report key: 20094979 · Received August 29, 2024

    Report

    Report Number
    3010457505-2024-00327
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    June 21, 2024
    Report Date
    October 1, 2024
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE DERMATITIS CANNOT BE RULED OUT. DERMATITIS IS AN EXPECTED EVENT WITH OPTUNE GIO DEVICE USE (EF-11 0% AND 2% EF-14 OPTUNE ARM).

    Additional Manufacturer Narrative · 0

    ON SEPTEMBER 11, 2024, NOVOCURE RECEIVED ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER (HCP), THAT CONFIRMED THE PATIENT EXPERIENCED A SEVERE SKIN REACTION RELATED TO THE OPTUNE GIO ARRAY ADHESIVE DESCRIBED AS DERMATITIS AND ULCERATION WITH NO SUPERIMPOSED INFECTION. TREATMENT INCLUDED A METHYLPREDNISOLONE DOSE PACK. THE HCP ASSESSED THE EVENT AS RELATED TO OPTUNE GIO THERAPY. REPORTEDLY, THE PATIENT DISCONTINUED OPTUNE GIO THERAPY DUE TO TUMOR PROGRESSION.

    Description of Event or Problem · 0

    A 66-YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) STARTED OPTUNE GIO THERAPY ON (B)(6) 2024. DURING REVIEW OF AN AVAILABLE MEDICAL RECORD, RECEIVED BY NOVOCURE ON (B)(6) 2024, IT WAS DISCOVERED THAT DURING A RADIATION ONCOLOGY FOLLOW UP VISIT ON (B)(6) 2024, THE PATIENT EXPERIENCED A SIGNIFICANT REACTION TO OPTUNE GIO ARRAY ADHESIVE DESCRIBED AS DERMATITIS AND PRURITUS. THE PATIENT WAS TREATED ACUTELY WITH AN INTRAMUSCULAR DEXAMETHASONE INJECTION AND PRESCRIBED A METHYLPREDNISOLONE DOSE PACK AND CLOBETASOL CREAM TO APPLY TO THE SCALP PRIOR TO ARRAY PLACEMENT. OPTUNE GIO THERAPY WAS TEMPORARILY DISCONTINUED AND THEN RESUMED. THE PRESCRIBING PHYSICIAN WAS CONTACTED FOR FURTHER DETAILS WITHOUT REPLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356474 OPTUNE GIO OPTUNE GIO NZK NOVOCURE GMBH TFH9100

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other AMLODIPINE BESYLATE.| ATORVASTATIN CALCIUM.| DEXAMETHASONE.| DIPHENHYDRAMINE.| GLUCOSAMINE SULFATE.| HYDRALAZINE HYDROCHLORIDE.| LEVETIRACETAM.