BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR INJECTION STENT

    MDR report key: 678200 · Received November 23, 2005

    Report

    Report Number
    6000043-2005-00111
    Event Type
    Malfunction
    Date Received
    November 23, 2005
    Date of Event
    November 1, 2005
    Report Date
    November 1, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR A THERAPEUTIC UROLOGICAL STENT REPLACEMENT PROCEDURE, AS THEY WERE REMOVING THE DEVICE FROM THE PACKAGING THE END OF THE STENT FELL OFF. THIS COMPLAINT IS LINKED TO MEDWATCH 6000043-2005-000112 AS THE ISSUES OCCURRED DURING PREPARATION FOR THE SAME PROCEDURE. THERE WAS NO ILL EFFECT SUSTAINED TO THE PATIENT. A THIRD STENT WAS SUCCESSFULLY ULTILIZED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR INJECTION STENT URETERAL STENT FAD BOSTON SCIENTIFIC CORPORATION * 7809078

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other