BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-FLEX DOUBLE PIGTAIL STENT SET

    MDR report key: 642817 · Received October 19, 2005

    Report

    Report Number
    1825146-2005-00014
    Event Type
    Injury
    Date Received
    October 19, 2005
    Manufacturer
    COOK UROLOGICAL, INC.
    Product Code
    FAD
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES: "STENT INSERTED 5/15/2005. STENT REMOVED 7/20/2005. STENT BROKEN, PIECE FOUND IN BLADDER AND THREE FRAGMENTS IN THE RIGHT URETER. OPEN SURGERY REQUIRED TO REMOVE PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-FLEX DOUBLE PIGTAIL STENT SET URETERAL PIGTAIL STENT FAD COOK UROLOGICAL, INC. NA 1005723

    Patients

    Seq Age Sex Outcome Treatment
    1 *