BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 5002794 · Received August 14, 2015

    Report

    Report Number
    3002808486-2015-00092
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    August 20, 2013
    Report Date
    August 10, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    00827002483736
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE: (B)(4). SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6) 2013 AT (B)(6)." PATIENT OUTCOME: IT IS ALLEGED THAT PT WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538465 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK 00827002483736

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Life Threatening