BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUFLEX URETERAL STENT

    MDR report key: 697430 · Received September 29, 2005

    Report

    Report Number
    6000043-2005-00069
    Event Type
    Malfunction
    Date Received
    September 29, 2005
    Date of Event
    July 29, 2005
    Report Date
    September 1, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A THERAPEUTIC UROLOGICAL PROCEDURE, ONE TIP OF THIS STENT DETACHED AS THEY WERE REMOVING THE SUTURE. THERE WAS NO PT COMPLICATIONS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUFLEX URETERAL STENT URETERAL STENTS FAD BOSTON SCIENTIFIC NA 7699219

    Patients

    Seq Age Sex Outcome Treatment
    1 NA