BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 11949736 · Received June 7, 2021

    Report

    Report Number
    3009453079-2021-00174
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    March 30, 2021
    Report Date
    June 7, 2021
    Manufacturer
    NOVOCURE, LTD.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE MEDICAL OPINION IS THAT A CONTRIBUTION TO THE EVENT CANNOT BE EXCLUDED. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE IN THE PATIENT INCLUDE: PRIOR RADIATION, UNDERLYING CANCER DISEASE, AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. WOUND DEHISCENCE 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/TMZ ARM OF THE TRIAL (<1%) ONLY.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD MALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2018. ON MARCH 23, 2021, NOVOCURE WAS INFORMED BY THE PATIENT THAT HE HAD DEVELOPED AN ULCER NEAR THE CRANIOTOMY SURGICAL RESECTION SITE (DATE OF LATEST SURGICAL RESECTION NOT PROVIDED). WOUND REVISION SURGERY AND CRANIUM HARDWARE PLATE REMOVAL WERE SCHEDULED FOR (B)(6) 2021, FOLLOWED BY PLACEMENT OF A NEGATIVE PRESSURE PAD FOR ONE MONTH. ON (B)(6) 2021, THE PATIENT REPORTED TO NOVOCURE THAT DURING A TRANSDUCER ARRAY EXCHANGE, SCALP SKIN LIFTED OFF AT THE SURGICAL WOUND SITE. ON (B)(6)2021, THE PATIENT RESUMED OPTUNE THERAPY, PLACING THE TRANSDUCER ARRAYS ON THE SCALP TO AVOID THE SURGICAL WOUND SITE. THE PATIENT REPORTED THAT HE HAD TREATED THE AFFECTED AREA WITH AN UNSPECIFIED TOPICAL POWDER. PER THE PRESCRIBING PHYSICIAN, THE PLACEMENT OF THE TRANSDUCER ARRAYS OVER THE SURGICAL RESECTION SITE HAD A POSSIBLE RELATION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844981 OPTUNE OPTUNE NZK NOVOCURE, LTD. TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention