BEUDAMED
    FDA Adverse Event Death Summary report: N

    CR BARD

    MDR report key: 406619 · Received July 22, 2002

    Report

    Report Number
    MW1025640
    Event Type
    Death
    Date Received
    July 22, 2002
    Date of Event
    June 9, 2001
    Report Date
    July 22, 2002
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A FEMOSTOP DEVICE WAS USED ON THE RIGHT FEMORAL GROIN AREA AFTER A HEART CATHETERIZATION ON A PT WITH HISTORY OF PHLEBITIS. IT WAS IN PLACE WITHOUT RELEASE OF PRESSURE FOR 19 HRS RESULTING IN A MASSIVE PULMONARY EMBOLI. MAXIMUM LENGTH OF USE BY MFR IS 7 HRS WITH RELEASE OF PRESSURE EVERY 1 TO 3 HRS FOR 5 MIN. ACCORDING TO CR BARD THIS PARTICULAR DEVICE WAS REPLACED WITH ANOTHER ONE IN 4/02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CR BARD FEMOSTOP GROIN COMPRESSOR AND REUSEABLE PUMP DXC RADI MEDICAL SYSTEMS AB FEMOSTOP SYSTEM *
    2 CR BARD FEMOSTOP GROIN COMPRESSOR AND REUSABLE PUMP DXC RADI MEDICAL SYSTEMS AB FEMOSTOP SYSTEM *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death