BEUDAMED
    FDA Adverse Event Other Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 707781 · Received April 14, 2006

    Report

    Report Number
    MW1038437
    Event Type
    Other
    Date Received
    April 14, 2006
    Date of Event
    March 2, 2006
    Report Date
    April 14, 2006
    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

    EXTREME PAIN FOR 2-3 WEEKS POST-UAE. SIX DAYS POST-UAE DEVELOPED BLADDER INFECTION. TREATED 2 RX WITH ANTIBIOTICS WITH NO IMPROVEMENT. BILATERAL FLANK PAIN. PAIN IN MIDDLE OF ABDOMEN WITH URINATION. FIVE WEEKS POST-UAE DEVELOPED LOWER BACK PAIN. CONCERNED THAT PRE-UAE DOCTORS MADE PROCEDURE SOUND SIMPLE AND DID NOT INFORM HER OF THE KNOWN RISKS AND ADVERSE EFFECTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other