BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 7057589 · Received November 24, 2017

    Report

    Report Number
    3002808486-2017-02289
    Event Type
    Injury
    Date Received
    November 24, 2017
    Report Date
    January 11, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). D4) CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. (B)(4). IT HAS NOT BEEN POSSIBLE TO INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVING WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2011". PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED THIS EVENT BASED ON AVAILABLE INFORMATION AT THE TIME OF COMPLAINT REGISTRATION. NEW INFORMATION WAS PROVIDED IDENTIFYING THAT THE PRODUCT WAS ACTUALLY A COOK INC. MANUFACTURED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836856 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening