BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DIVERSION SOFT STENT

    MDR report key: 647943 · Received September 28, 2005

    Report

    Report Number
    6000043-2005-00044
    Event Type
    Malfunction
    Date Received
    September 28, 2005
    Date of Event
    April 14, 2005
    Report Date
    April 19, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A THERAPEUTIC UROLOGICAL STENT WAS PLACED AND IN THE PT FOR TWO WEEKS. WHEN THE DOCTOR WENT TO REMOVE THE STENT, PART OF IT DETACHED IN THE PT AND WAS THEN REMOVED THROUGH AN ENDOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URINARY DIVERSION SOFT STENT URETERAL STENTS FAD BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA