BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSEAL

    MDR report key: 1052874 · Received May 17, 2008

    Report

    Report Number
    1052874
    Event Type
    Malfunction
    Date Received
    May 17, 2008
    Date of Event
    February 22, 2008
    Report Date
    May 17, 2008
    Manufacturer
    ST. JUDE CARDIOLOGY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ANGIOSEAL DEVICE AFTER RETURNING FROM PROCEDURE IN CARDIAC CATH LAB. A HEMATOMA WAS NOTED. PRESSURE WAS APPLIED, HEMATOMA RESOLVED. NO DELAY IN DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSEAL VASCULAR CLOSURE DEVICE MGB ST. JUDE CARDIOLOGY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR CARDIAC DRUGS| CARDIAC DRUGS