BEUDAMED
    FDA Adverse Event Death Summary report: N

    NOVASURE

    MDR report key: 6171872 · Received December 13, 2016

    Report

    Report Number
    MW5066659
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    July 11, 2016
    Report Date
    December 10, 2016
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(4). I HAD PROCEDURE DONE IN 2011 FOR HEAVY PERIODS AND BACK PAIN AND CRAMPS. I WAS TOLD IT WOULD STOP MY PERIODS AND THAT I WOULD NEVER HAVE CHILDREN AGAIN. MY PERIODS STARTED OUT AS BEING LIGHT THEN RETURNED TO BE HEAVY DARK BLOOD. MY CRAMPS WERE HORRIBLE, I WAS ALWAYS BLOATED AND HAD SEVERE BACK PAIN. IN (B)(6) 2016 I FOUND OUT I WAS PREGNANT. THE DOCTOR WAS SHOCKED SAYING I COULDN'T HAVE CHILDREN. THROUGH ULTRASOUND IT SHOWED I WAS 6 WEEKS PREGNANT WITH ANOTHER SAC FILLED WITH FLUID. I WAS HIGH RISK AND SENT TO A SPECIALIST. EVERY TIME I HAD AN ULTRASOUND MY BABY WAS GROWING AND SO WAS THE OTHER SAC. THEY WERE CONCERNED ABOUT THE PLACENTA. MY SON (B)(6) WAS BORN STILL AT (B)(6) MONTHS. HE WEIGHED (B)(6). AFTER I GAVE BIRTH (VAGINAL) MY PLACENTA WOULD NOT COME OUT. I HEMORRHAGED AND HAD TO GO TO OPERATING ROOM TO STOP BLEEDING. PLACENTA WAS EMBEDDED INTO MY UTERUS. MY HGB WAS 7.5. I AM NOW SCHEDULED FOR A HYSTERECTOMY (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819658 NOVASURE MNB HOLOGIC

    Patients

    Seq Age Sex Outcome Treatment
    1 42.000 YR Death| H| L| O| R EFFEXOR ER, TOPROL