BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UTERINE ARTERY EMBOLIZATION

    MDR report key: 386161 · Received March 29, 2002

    Report

    Report Number
    MW1024542
    Event Type
    Injury
    Date Received
    March 29, 2002
    Date of Event
    March 11, 2002
    Report Date
    March 29, 2002
    Manufacturer
    *
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DURING UAE COMPRESSION OF ARTERY TO STOP BLEEDING, CREATED A PSEUDO ANEURYSM. REQUIRED ADD'L SURGERY THREE DAYS LATER TO REPAIR THE FEMORAL ARTERY. SINCE UNDERGOING THE UAE PT HAD SEVERE PAIN, NAUSEA AND VOMITING. PT IS STILL RECOVERING FROM THE SECOND PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention