BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 11815971 · Received May 12, 2021

    Report

    Report Number
    3009453079-2021-00173
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 12, 2021
    Manufacturer
    NOVOCURE, LTD.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE OPINION IS THAT THE SKIN LACERATION WAS RELATED TO OPTUNE. THE FALL WAS UNRELATED TO OPTUNE. SKIN LACERATION 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). FALL 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 (8% AND 3% IN OPTUNE/TMZ AND TMZ ARMS RESPECTIVELY).

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2021. ON (B)(6) 2021, THE DAUGHTER REPORTED THAT THE PATIENT LOST HER BALANCE AND FELL SUSTAINING A LACERATION ON THE SCALP FROM A BROKEN TRANSDUCER ARRAY DISC. THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY DEPARTMENT AND RECEIVED 9 SURGICAL STAPLES TO CLOSE THE SCALP LACERATION. AFTER SEVERAL ATTEMPTS OF CONTACT, THE PRESCRIBING PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707854 OPTUNE OPTUNE NZK NOVOCURE, LTD. TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention