BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 4643249 · Received March 30, 2015

    Report

    Report Number
    3002808486-2015-00030
    Event Type
    Injury
    Date Received
    March 30, 2015
    Report Date
    February 26, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG: UNKNOWN BUT REFERRED TO AS A COOK CELECT VENA CAVA FILTER.; SINCE CATALOG IS UNKNOWN THE 510(K) COULD BE EITHER K090140 OR K073374. INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO COMPLAINANT: THE LEG OF A CELECT FILTER HAD FRACTURED AND EMBOLIZED. THE PHYSICIAN WAS UNABLE TO REMOVE THE PULMONARY PIECE, BUT THE REST OF THE FILTER WAS SUCCESSFULLY REMOVED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208999 UNK DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention