BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BANDER URETERAL DIVERSION STENT SET

    MDR report key: 401432 · Received June 20, 2002

    Report

    Report Number
    401432
    Event Type
    Injury
    Date Received
    June 20, 2002
    Date of Event
    April 16, 2002
    Report Date
    May 23, 2002
    Manufacturer
    COOK UROLOGICAL
    Product Code
    EYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE FOR REMOVAL OF STENT, THE STENT BROKE APPROXIMATELY 3" OF DISTAL PORTION REMAINED IN PT. F/U PROCEDURE DONE IN 2002 WAS SUCCESSFUL IN REMOVING REMAINING PORTION OF STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BANDER URETERAL DIVERSION STENT SET URETERAL DIVERSION STENT EYB COOK UROLOGICAL 025226 F965906

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention