BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP GOLD

    MDR report key: 1542765 · Received November 3, 2009

    Report

    Report Number
    1542765
    Event Type
    Malfunction
    Date Received
    November 3, 2009
    Date of Event
    October 23, 2009
    Report Date
    November 3, 2009
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE APPLYING A FEMOSTOP TO A PATIENT POST CARDIAC CATHETERIZATION, THE FEMOSTOP GAUGE MALFUNCTIONED AND DID NOT WORK. IT WAS IDENTIFIED THAT THERE IS A "SAFETY" MECHANISM SO THAT WHEN THE RED TAB IS REMOVED, IF A NUMBER DOES NOT APPEAR IN THE DISPLAY, THEN THE DEVICE SHOULD BE CONSIDERED DEFECTIVE AND NOT USED.

    Description of Event or Problem · 1

    WHILE APPLYING A FEMOSTOP TO A PATIENT POST CARDIAC CATHETERIZATION, THE FEMOSTOP GAUGE MALFUNCTIONED AND DID NOT WORK. IT WAS IDENTIFIED THAT THERE IS A "SAFETY" MECHANISM SO THAT WHEN THE RED TAB IS REMOVED, IF A NUMBER DOES NOT APPEAR IN THE DISPLAY, THEN THE DEVICE SHOULD BE CONSIDERED DEFECTIVE AND NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP GOLD CLOSURE DEVICE DXC RADI MEDICAL SYSTEMS AB * 092706

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR