BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS URETERAL STENT

    MDR report key: 2071415 · Received April 15, 2011

    Report

    Report Number
    MW5020372
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STENT BROKE APART WHEN DOCTOR WAS TRYING TO PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARIS URETERAL STENT STENT FAD BOSTON SCIENTIFIC 6FX24CM 13267209

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR