BEUDAMED
    FDA Adverse Event Other Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 564434 · Received December 15, 2004

    Report

    Report Number
    MW1033812
    Event Type
    Other
    Date Received
    December 15, 2004
    Date of Event
    January 3, 2002
    Report Date
    December 15, 2004
    Manufacturer
    *
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LARGE UPPER RIGHT LEG HEMATOMA AT CATHETER INSERTION SITE, 5 TO 6 INCHES IN DIAMETER. RIGHT LEG PAIN AND WEAKNESS, TWO WEEK DURATION. CONSTANT FEVER, CHILLS, ABDOMINAL CRAMPING, DURATION THREE MONTHS. MULTIPLE URINARY TRACT INFECTIONS, RESISTANT TO ANTIBIOTICS. FLU LIKE SYMPTOMS BEGINNING ONE MONTH POST UAE. CHRONIC PERSISTENT VAGINAL DISCHARGE, AMMONIA ODOR. CONSTANT LRQ PAIN. OCCASIONAL RIGHT SIDED STABBING PAIN LRQ. PERFUSE VAGINAL DISCHARGE THREE MONTHS POST UAE. SEVERE ABDOMINAL CRAMPS WITH VISIT TO ER. ABOUT 3 MONTHS POST UAE, FIBROID WAS HANGING OUT OF CERVIX. DAILY CRAMPING, CHILLS, AND PERFUSE VAGINAL DISCHARGE SUBSIDED. VAGINAL DISCHARGE WITH AMMONIA ODOR CONTINUES. VAGINAL BLEEDING AND CRAMPING INCREASING, WORSE WITH EACH MENSTRUAL PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE ARTERY EMBOLIZATION * NAJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other