BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABALTE 2100

    MDR report key: 8543600 · Received April 24, 2019

    Report

    Report Number
    9615058-2018-00007
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    October 16, 2018
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P040003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2018 INSIGHTEC WERE NOTIFIED BY OUR INSIGHTEC REPRESENTATIVE, INSIGHTEC COMMERCIAL DEVELOPMENT& INTERNATIONAL DIRECTOR, THAT DURING A CONVERSATION WITH THE SITE ((B)(6)) CHAIRMAN MR. (B)(6) MENTIONED, THAT A PATIENT UNDERWENT EXABLATE TREATMENT FOR THEIR UTERINE FIBROIDS THAT RESULTED IN BOWEL PERFORATION. NO ADDITIONAL DATA WAS GIVEN AT THIS TIME. DESPITE INSIGHTEC ATTEMPTS TO GET THE SITE TO PROVIDE MORE INFORMATION ON THIS CASE, ALL ATTEMPTS RESULTED IN NO COMMUNICATION THE SITE. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340209 EXABALTE 2100 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R