BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGHTEC EXABLATE 2000

    MDR report key: 1593109 · Received January 28, 2010

    Report

    Report Number
    MW5014591
    Event Type
    Injury
    Date Received
    January 28, 2010
    Date of Event
    January 1, 2009
    Report Date
    January 28, 2010
    Manufacturer
    INSIGHTEC
    Product Code
    MIK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM NOT SURE THAT THE DEVICE -INSIGHTEC EXABLATE 2000- HAD ANYTHING TO DO WITH MY DIAGNOSIS OF UTERINE CANCER, BUT I WANTED TO REPORT IT, JUST IN CASE OTHER WOMEN WHO WERE TREATED WITH HIFU FOR UTERINE FIBROIDS LATER DEVELOPED UTERINE CANCER. I WAS TREATED AT (B) (6) WITH HIFU, USING THE INSIGHTEC EXABLATE 2000, IN 2007. I DEVELOPED UTERINE CANCER APPROXIMATELY A HALF AFTER HAVING THE TREATMENT -DIAGNOSED IN 2009-. FORTUNATELY, IT WAS CAUGHT AT STAGE 1 AND I HAD A HYSTERECTOMY -IN (B) (6) 2009- AND HAVE NOT HAD TO HAVE ANY FURTHER TREATMENT. I DID REPORT THIS TO DR (B) (6), WHO ADMINISTERED THE TREATMENT TO ME, AT (B) (6), AND TO INSIGHTEC. DIAGNOSIS OR REASON FOR USE: LARGE UTERINE FIBROID - IN 2007 AT (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGHTEC EXABLATE 2000 NONE MIK INSIGHTEC

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| O