BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE 6FR

    MDR report key: 615421 · Received June 17, 2005

    Report

    Report Number
    615421
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    March 22, 2005
    Report Date
    April 15, 2005
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    12CM X 13CM GROIN HEMATOMA AFTER PERCLOSE CLOSURE AFTER CARDIAC CATLERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE 6FR VASCULAR CLOSURE DEVICE MGB ABBOTT VASCULAR 12763 22101-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other