BEUDAMED
    FDA Adverse Event Summary report: N

    EXPRESS (R) LD ILIAC / BILIARY

    MDR report key: 2180098 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03303
    Date Received
    July 27, 2011
    Report Date
    August 14, 2007
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS VOLUNTARY REPORT #: (B)(4).THE MANUFACTURER REPORT NUMBER WAS ORIGINALLY 6000089-2007-01245 AND HAD CHANGED TO 2134265-2011-03303 AS BSC HAS DISCONTINUED THE USE OF THE SPECIAL REPORTING NUMBERS GRANTED BY THE FDA AND ARE UTILIZING THE REGULATION DEFAULT SITE ESTABLISHMENT REGISTRATIONS NUMBERS FOR REPORTING MDR'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) LD ILIAC / BILIARY STENT, ILIAC NIO H74938046740750

    Patients

    Seq Age Sex Outcome Treatment
    1