BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1180505 · Received September 26, 2008

    Report

    Report Number
    2954310-2008-81675
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    July 11, 2002
    Report Date
    September 25, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE PT DURING THE IMPLANT PROCEDURE THEIR COLON WAS PERFORATED RESULTING IN AN INFECTION POST IMPLANT. THE PT UNDERWENT SURGICAL INTERVENTION TO CORRECT THE ISSUE. THE PT REQUIRES THE USE OF A COLOSTOMY BAG NOW. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS 13443

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention