BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARCLOSE

    MDR report key: 2190236 · Received August 1, 2011

    Report

    Report Number
    2190236
    Event Type
    Malfunction
    Date Received
    August 1, 2011
    Date of Event
    February 16, 2009
    Report Date
    May 22, 2009
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE WIRE AND CATHETER WERE REMOVED, THE SHEATH WAS REMOVED. THE STARCLOSE DEVICE MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *