BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 14114231 · Received April 14, 2022

    Report

    Report Number
    3010457505-2022-00207
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    March 24, 2022
    Report Date
    April 14, 2022
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION OF THE ARRAY PLACEMENT TO THE EVENT CANNOT BE RULED OUT. MEDICAL DEVICE SITE REACTION IS AN EXPECTED EVENT WITH DEVICE USE AND WAS REPORTED AS AN ADVERSE EVENT IN THE EF-14 TRIAL OF OPTUNE TOGETHER WITH TEMOZOLOMIDE (TMZ) COMPARED TO TMZ ALONE IN PATIENTS WITH NEWLY DIAGNOSED GBM IN THE OPTUNE ARM OF THE TRIAL (53%).

    Description of Event or Problem · 0

    A (B)(6)-YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2020. NOVOCURE RECEIVED A REPORT ON (B)(6) 2022, THAT THE PATIENT REPORTEDLY EXPERIENCED A SKIN IRRITATION AND A WOUND ON HER HEAD. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED ON AN UNSPECIFIED DATE FOR FIVE DAYS DUE TO WORSENED SKIN IRRITATION/WOUND ON THE FOREHEAD. NO FURTHER INFORMATION PROVIDED. PATIENT CONTINUED WITH OPTUNE THERAPY. AFTER SEVERAL ATTEMPTS OF CONTACT, PRESCRIBING PHYSICIAN DID NOT REPLY WITH ANY ADDITIONAL INFORMATION OR CAUSALITY ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210092 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization NOT PROVIDED.