BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1630819 · Received March 5, 2010

    Report

    Report Number
    1630819
    Event Type
    Malfunction
    Date Received
    March 5, 2010
    Date of Event
    February 3, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CAP ON THE INTERNAL STIFFENER BROKE WHEN REMOVED FROM THE PT. THE PT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC URETERAL STENT SYSTEM FAD BOSTON SCIENTIFIC * 12864795

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR