BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP

    MDR report key: 1192769 · Received October 8, 2008

    Report

    Report Number
    2647580-2008-00591
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 18, 2008
    Manufacturer
    PONCE - USS
    Product Code
    GDW
    PMA / PMN Number
    K001895
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: AFTER THE DEVICE WAS APPLIED, THE DONUTS WERE NORMAL, BUT THE ANASTOMOSIS WAS REDONE LOWER BECAUSE OF A LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP NONE GDW PONCE - USS P8D0594J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention