BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 14496075 · Received May 25, 2022

    Report

    Report Number
    3010457505-2022-00209
    Event Type
    Injury
    Date Received
    May 25, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 25, 2022
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NOVOCURE OPINION IS THAT THE CONTRIBUTION OF THE ARRAY PLACEMENT TO THE EVENT CANNOT BE RULED OUT. ABSCESS 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 BOTH ARMS OF THE TRIAL (<1% AND <1% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY).

    Description of Event or Problem · 0

    A (B)(6) MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2021. ON (B)(6) 2022, PATIENT REPORTED LOWER COMPLIANCE WITH OPTUNE THERAPY DUE TO A SKIN ISSUE. THE PHYSICIAN PRESCRIBED UNSPECIFIED TREATMENT. ON (B)(6) 2022, NOVOCURE WAS INFORMED THE PATIENT HAD LOWER USAGE DUE TO A HOSPITALIZATION AND A SKIN ISSUE DESCRIBED AS AN ABSCESS ON THE BACK OF THE SCALP. ON (B)(6) 2022, NOVOCURE EMPLOYEE CONFIRMED THE PATIENT WAS HOSPITALIZED AND UNDERWENT SURGERY FOR THE ABSCESS ON THE SCALP. THE PRESCRIBING PHYSICIAN DID NOT PROVIDE ANY ADDITIONAL INFORMATION OR A CAUSALITY ASSESSMENT TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2114889 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention| H