BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 1811928 · Received August 18, 2010

    Report

    Report Number
    MW5017142
    Event Type
    Injury
    Date Received
    August 18, 2010
    Date of Event
    September 1, 2007
    Report Date
    August 18, 2010
    Product Code
    NAJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EXTREME PAIN FOLLOWING UAE FOR TWO WEEKS. INABILITY TO CONCEIVE. MYOMECTOMY WAS PERFORMED FOR INFERTILITY. A 20 CM CALCIFIED FIBROID WAS REMOVED. TWO PREGNANCIES, ONE NORMAL DELIVERY. SECOND DELIVERY, EXPERIENCED UTERINE ATONY AND POST PARTUM HEMORRHAGE. D&C REVEALED CALCIFIED FISSURES IN THE LINING OF THE UTERUS. THOUGHT TO BE CAUSED BY UAE.

    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