BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICKSEAL FEMORAL ARTERY CLOSURE DELIVERY SYSTEM

    MDR report key: 427011 · Received November 6, 2002

    Report

    Report Number
    2134280-2002-00004
    Event Type
    Injury
    Date Received
    November 6, 2002
    Date of Event
    October 4, 2002
    Report Date
    November 5, 2002
    Manufacturer
    SUB-Q, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002 A QUICKSEAL DEVICE WAS USED TO ACHIEVE HEMOSTASIS OF THE ARTERIAL PUNCTURE SITE IN THE RIGHT GROIN FOLLOWING A DIAGNOSTIC CATHETERIZATION PROCEDURE. IN 2002 THE PATIENT WAS DIAGNOSED WITH ISCHEMIA OF THE RIGHT FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICKSEAL FEMORAL ARTERY CLOSURE DELIVERY SYSTEM VASCULAR CLOSURE MGB SUB-Q, INC. G100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention