BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 935982 · Received October 23, 2007

    Report

    Report Number
    MW5004235
    Event Type
    Injury
    Date Received
    October 23, 2007
    Date of Event
    October 12, 2006
    Report Date
    October 23, 2007
    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

    PATIENT FIRST INFORMED ABOUT THE USE OF THE COIL IN THE ARTERIES FIVE MONTHS POST UAE WHEN EXPERIENCING SIGNIFICANT COMPLICATIONS. SHE HAS RIGHT LEG NUMBNESS PAIN ON THE LEFT SIDE OF THE PELVIS IN THE AREA OF THE COIL, PINCHING SENSATION LLQ, ABNORMALLY FREQUENT MENSTRUATION, MALAISE, CONSTIPATION, INTESTINAL PAIN AND GASTRIC DISTRESS, RECTAL PRESSURE, BOWEL INFLAMMATION, FECAL INCONTINENCE, FOUL VAGINAL ODOR, FOUL BREATH, CHEST AND FACE SKIN DISCOLORATION, INABILITY TO WORK FOR TWO MONTHS. ONE YEAR POST UAE BOWEL PROBLEMS CONTINUE, AND RIGHT LEG NUMBNESS. WALKING CAUSES PINCHING PAIN IN THE LLQ. PHYSICAL, SOCIAL, AND ECONOMIC COSTS HAVE BEEN SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UTERINE ARTERY EMBOLIZATION COIL AND UNKNOWN EMBOLIC MATERIAL NAJ

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other