BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 7863364 · Received September 11, 2018

    Report

    Report Number
    3002808486-2018-01064
    Event Type
    Malfunction
    Date Received
    September 11, 2018
    Report Date
    November 13, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK (B)(4) INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK GUNTHER TULIP FILTER E3) OCCUPATION: NON-HEALTHCARE PROFESSIONAL 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

    ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC.

    Description of Event or Problem · 0

    IT IS ALLEGED THAT "[PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2012". 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
    706473 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening