BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5722317 · Received June 14, 2016

    Report

    Report Number
    3002808486-2016-00504
    Event Type
    Injury
    Date Received
    June 14, 2016
    Report Date
    June 3, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS EITHER GUNTHER TULIP MREYE, GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER OR COOK CELECT PLATINUM. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. IMPLANT DATE: UNKNOWN AS INFORMATION WAS NOT PROVIDED. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426, K061815, K073374, K090140, K112119, K121057 OR K121629. DEVICE MFR DATE: UNKNOWN AS LOT# IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK IVC FILTER". 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
    377486 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening