BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX

    MDR report key: 3082388 · Received April 8, 2013

    Report

    Report Number
    3082388
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144440 ZENITH FLEX SYSTEM, ENDOVASCULAR GRAFT MIH COOK INCORPORATED TFFB-26-82-ZT *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR