BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP GOLD

    MDR report key: 1568640 · Received December 7, 2009

    Report

    Report Number
    1568640
    Event Type
    Malfunction
    Date Received
    December 7, 2009
    Date of Event
    November 11, 2009
    Report Date
    December 7, 2009
    Manufacturer
    RADI MEDICAL SYSTEMS AB
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN ARTERIAL SHEATH WAS DISCONTINUED BY A PHYSICIAN. PRESSURE WAS APPLIED TO THE SITE, AND FEMSTOP APPLIED PER PROTOCOL. WHEN INFLATED, THE FEMSTOP DID NOT READ PRESSURE AND AFTER SOME TIME READ EEE. PATIENT'S TOES WERE COOL AND DUSKY. FEMSTOP REMOVED AND MANUAL PRESSURE APPLIED FOR 10 MINUTES; PATIENT'S LEG RETURNED TO NORMAL COLOR AND TEMPERATURE. NO HARM TO PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR