BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT VENA CAVA FILTER

    MDR report key: 1737917 · Received June 22, 2010

    Report

    Report Number
    MW5016480
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    April 12, 2010
    Report Date
    June 22, 2010
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RETROPERITONEAL HEMATOMA AND HEMORRHAGE DUE TO MULTIPLE PERFORATIONS OF INFERIOR VENA CAVA BY PRONGS OF CAVAL FILTER. FILTER PLACED (B)(6) 2009 "COOK CELECT VENA CAVA FILTER". PERFORATION TOOK PLACE BETWEEN (B)(6) 2010 AND (B)(6) 2010 FOLLOWING ELECTIVE SURGERY TO REANASTOMOSE FALLOPIAN TUBES. DATES OF USE: (B)(6) 2009 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: HISTORY OF PULMONARY EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT VENA CAVA FILTER IVC FILTER DTK IGTCFS-S5-FEM-CELECT E2471868

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death