BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTINOL NITINOL BILIARY STENT SYSTEM

    MDR report key: 606438 · Received May 18, 2005

    Report

    Report Number
    6000093-2005-00593
    Event Type
    Malfunction
    Date Received
    May 18, 2005
    Report Date
    April 20, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT CODE LABEL ON THE SENTINOL NITINOL BILIARY STENT SYSTEM WAS INCORRECT. IT WAS ALSO REPORTED THAT THE LABEL PRINTING WAS OF POOR QUALITY AND DIFFICULT TO READ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTINOL NITINOL BILIARY STENT SYSTEM BILIARY STENT FGE BOSTON SCIENTIFIC NA 7241003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN