BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINEXX BILIARY STENT

    MDR report key: 592780 · Received April 12, 2005

    Report

    Report Number
    9681442-2005-00025
    Event Type
    Malfunction
    Date Received
    April 12, 2005
    Date of Event
    March 11, 2005
    Report Date
    March 16, 2005
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE LUMINEXX STENT HAS A FRACTURE IN IT. STENT WAS PLACED INTO SUBCLAVIAN VEIN 19 MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINEXX BILIARY STENT BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTE * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR