BEUDAMED
    FDA Adverse Event Summary report: N

    FEMOSTOP GOLD

    MDR report key: 3101842 · Received May 7, 2013

    Report

    Report Number
    3101842
    Date Received
    May 7, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DXC
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RETURNED TO CARDIAC FLOOR FROM CATHERIZATION LAB WITH FEMOSTOP ON LEFT GROIN. PATIENT COMPLAINED OF PAIN AT THE SITE- PLASTIC COVERING HAD NOT BEEN REMOVED FROM THE DOME PRIOR TO PLACING IT ON PATIENT. CHARGE NURSE REMOVED PLASTIC COVERING AND FEMOSTOP WAS REAPPLIED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?FEMOSTOP COMPRESSION DEVICE FOR EXTERNAL COMPRESSION OF THE FEMORAL ARTERY/VEIN. IT IS USED TO ACHIEVE HEMOSTASIS AFTER REMOVAL OF FEMORAL ARTERIAL AND VENOUS INTRAVASCULAR SHEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199841 FEMOSTOP GOLD CLAMP, VASCULAR DXC ST. JUDE MEDICAL C11165 115474

    Patients

    Seq Age Sex Outcome Treatment
    1 *