BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTUNE

    MDR report key: 6060266 · Received October 27, 2016

    Report

    Report Number
    3009453079-2016-00077
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 3, 2016
    Report Date
    September 16, 2022
    Manufacturer
    NOVOCURE GMBH
    Product Code
    NZK
    PMA / PMN Number
    P100034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON AUGUST 23, 2022, NOVOCURE DISCOVERED THAT THE INITIAL SUBMITTED MEDICAL DEVICE REPORT HAD A TYPO IN THE MODEL NUMBER FOR THE OPTUNE DEVICE IN SECTION D4-SUSPECT MEDICAL DEVICE MODEL NUMBER. CORRECTED MODEL NUMBER IS TFH9000.

    Additional Manufacturer Narrative · 1

    NOVOCURE AGREES WITH THE TREATING PHYSICIAN THAT THE EVENT IS NOT RELATED TO OPTUNE. CONTRIBUTING FACTORS FOR WOUND INFECTION IN THIS PATIENT INCLUDE PRIOR RADIATION, CHEMOTHERAPY AND PRIOR SURGERY AFFECTING SKIN INTEGRITY. POSTOPERATIVE WOUND INFECTION WAS REPORTED AS AN ADVERSE EVENT IN THE EF-14 PIVOTAL 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%).

    Description of Event or Problem · 1

    PATIENT WITH NEWLY DIAGNOSED GLIOBLASTOMA BEGAN OPTUNE THERAPY ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT WAS ADMITTED FROM CLINIC AFTER NOTING THAT A SMALL PART OF HER RESECTION WOUND HAD A LUMP THAT WAS DRAINING FLUID. OPTUNE THERAPY WAS DISCONTINUED UPON ADMISSION. THE PATIENT ELECTED TO UNDERGO A RIGHT CRANIAL WOUND EXPLORATION AND WASHOUT. INTRAOPERATIVELY THERE WERE NO FINDINGS OF GROSS PURULENCE; RATHER IT APPEARED TO BE A SMALL STITCH ABSCESS. FINAL DIAGNOSIS WAS POSTOPERATIVE SUPERFICIAL WOUND INFECTION. THE PATIENT WAS TREATED WITH PAIN MEDICATIONS AND STARTED ON A BROAD SPECTRUM ANTIBIOTIC, WHICH WAS LATER REPLACED WITH A 10 DAY COURSE OF ORAL SULFAMETHOXAZOLE/TRIMETHOPRIM AND AMOXICILLIN/CLAVULANATE. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION ON (B)(6) 2016. PATIENT PLANNED TO RESTART OPTUNE THERAPY UPON COMPLETION OF ANTIBIOTIC COURSE. PER THE TREATING PHYSICIAN, THE EVENT WAS NOT RELATED TO OPTUNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712790 OPTUNE OPTUNE NZK NOVOCURE GMBH TFH9000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization CYANOCOBALAMIN| FAMOTIDINE| FOLIC ACID| CYANOCOBALAMIN| FAMOTIDINE| FOLIC ACID