BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK INC.

    MDR report key: 758239 · Received September 7, 2006

    Report

    Report Number
    MW1040348
    Event Type
    Injury
    Date Received
    September 7, 2006
    Date of Event
    January 24, 2004
    Report Date
    August 28, 2006
    Manufacturer
    COOK GROUP INCORPORATED
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PROBLEM: FULLY DILATED ASCENDING THORACIC W/ ANEURYSM (2X3CM). EVENT: REPAIRED W/ AN ABDOMINAL AORTIC STENT/GRAFT. RESULT: DEIVCE TOO BIG - 1. RIPPED ILIAC ARTERY 2. LEFT AND RIGHT CAROTID ARTERIES - EXTREMELY TORTUOUS. 3. NEUROLOGICAL PROBLEMS - A MASS IN BRAIN (NEAR PITUITARY GLAND). 4. LESION ON LIVER. 5. SEVERE HEADACHES. 6. VISUAL CHANGES. 7. BLOOD FLOW - PROBLEMS. 8. FEVER 100 DEG. @ 6 MOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK INC. AAA - ABDOMINAL ENDOVASCULAR STENT GRAFT AND MAIN BODY EXTEN MIH COOK GROUP INCORPORATED * *
    2 * * --- * * *
    3 * * --- *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| S