BEUDAMED
    FDA Adverse Event Death Summary report: N

    UTERINE MORCELLATOR

    MDR report key: 3556343 · Received January 2, 2014

    Report

    Report Number
    MW5033711
    Event Type
    Death
    Date Received
    January 2, 2014
    Date of Event
    October 20, 2011
    Report Date
    January 1, 2014
    Manufacturer
    UNK
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    (B)(6) OLD WHITE WOMAN WITH HX UTERINE LEIOMYOMA UNDERWENT LAPAROSCOPIC HYSTERECTOMY WITH IN SITU MORCELLATION. SURGERY WAS PERFORMED BY (B)(6) AT (B)(6). PATHOLOGICAL EXAM FOUND INCIDENTAL GRADE 3B LEIOMYOSARCOMA. WITHIN A FEW MONTHS IT WAS WIDELY METASTASIZED WITH NUMEROUS LOCAL RECURRENCES IN THE ABDOMEN. PT UNDERWENT SEVERAL COURSE OF CHEMOTHERAPY (GEM/TAX, DOXORUBICIN, DACARBAZINE) TO WHICH DISTANT METASTASES RESPONDED WELL. ATTEMPT AT SURGICAL DEBULKING FAILED BECAUSE OF DIFFUSE TUMOR SPREADING THROUGHOUT ABDOMEN. SHE DIED 19 MONTHS AFTER THE HYSTERECTOMY. MORCELLATION OF THE UTERUS MOST LIKELY WAS RESPONSIBLE FOR THE STRONG LOCAL RECURRENCES OF THE CANCER AND THE SHORT POSTOP SURVIVAL TIME. PAIN WAS SEVERE TOWARD THE END OF HER LIFE. GUIDELINES FOR UTERINE MORCELLATION NEED TO BE REVISED. PTS MUST BE BETTER INFORMED AS TO RISKS AND OLDER WOMEN WITH HIGHER PROBABILITY OF OCCULT CANCER SHOULD NOT BE CANDIDATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2222 UTERINE MORCELLATOR UTERINE MORCELLATOR HET UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| L| O| S