BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 1141888 · Received August 27, 2008

    Report

    Report Number
    MW5008127
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    February 8, 2006
    Report Date
    August 27, 2008
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GROIN HEMATOMA IMMEDIATELY POST UAE. VAGINAL BLEEDING FOR TWO DAYS UAE. NOW TWO YEARS FOUR MONTHS LATER, NOTHING RESEMBLING NORMAL MENSTRUATION OCCURS WITH OCCASIONAL BLOOD IN THE VAGINA. FSH, LH, ANA NORMAL. STEADY WEIGHT GAIN POST UAE 20 POUNDS TO DATE. SWELLING OF THE FEET BEGAN EIGHT MONTHS AGO, AND NOW THERE IS ADDITIONAL SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE ARTERY EMBOLIZATION NONE NAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Other