BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 11770725 · Received May 4, 2021

    Report

    Report Number
    3009453079-2021-00172
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    April 5, 2021
    Report Date
    May 4, 2021
    Manufacturer
    NOVOCURE, LTD.
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOVOCURE'S OPINION IS THAT A CONTRIBUTION TO THE EVENT CANNOT BE EXCLUDED. CONTRIBUTING FACTORS FOR WOUND DEHISCENCE IN THIS 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 FEMALE PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA (GBM) BEGAN OPTUNE THERAPY ON (B)(6) 2020. ON (B)(6) 2021, THE PATIENT REPORTED TO NOVOCURE THAT DURING A TRANSDUCER ARRAY EXCHANGE ON (B)(6) 2021, SKIN LIFTED OFF WITH THE ARRAYS, LEAVING A HOLE IN THE SCALP. OPTUNE THERAPY WAS TEMPORARILY DISCONTINUED. ON (B)(6) 2021, THE SPOUSE CLARIFIED THAT A PORTION OF THE PATIENT'S SURGICAL SCAB CAME OFF WITH THE TRANSDUCER ARRAYS, RE-OPENING THE SURGICAL INCISION AND EXPOSING THE CRANIUM BONE CLIPS IN THE SKULL (LAST SURGICAL RESECTION, (B)(6) 2019). ON (B)(6) 2021, DURING A FOLLOW-UP OFFICE VISIT, THE PRESCRIBER STATED THAT THE SURGICAL INCISION CONTINUED TO HEAL HOWEVER, HE PLANNED TO HAVE A SURGEON EVALUATE THE SURGICAL INCISION. PRESCRIBING PHYSICIAN WAS CONTACTED FOR ADDITIONAL PATIENT INFORMATION WITH NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668530 OPTUNE OPTUNE NZK NOVOCURE, LTD. TFH9100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other BETAMETHASONE DIPROPIONATE 0.05% TOPICAL OINTMENT| DIPHENHYDRAMINE| HYDROXYZINE| LEVOCETIRIZINE| MELATONIN| ONDANSETRON| PANTOPRAZOLE| PREDNISONE| TEMOZOLOMIDE| TRAZODONE