BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART CONTROL NITINOL STENT SYSTEM

    MDR report key: 3093291 · Received May 6, 2013

    Report

    Report Number
    9616099-2013-00272
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIO
    PMA / PMN Number
    P020036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196370 SMART CONTROL NITINOL STENT SYSTEM SELF EXPANDING STENTS (NIO) NIO CORDIS DE MEXICO NA 15646793

    Patients

    Seq Age Sex Outcome Treatment
    1