BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5962258 · Received September 20, 2016

    Report

    Report Number
    3002808486-2016-01092
    Event Type
    Injury
    Date Received
    September 20, 2016
    Report Date
    September 3, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER DATE OF IMPLANT: (B)(6) 2006. BASED ON THE ALLEGED IMPLANT DATE, IS COULD NOT BE A COOK CELECT, AS IT WAS FIRST MARKETED IN US IN 2007 (WITH 510(K) K061815). (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN IMPLANT DATE: (B)(6) 2006. BASED ON THE ALLEGED IMPLANT DATE, IS COULD NOT BE A COOK CELECT, AS IT WAS FIRST MARKETED IN US IN 2007 (WITH 510(K) K061815). (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 · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER IN (B)(6) 2006." PATIENT OUTCOME: IT IS ALLEGED THAT [PT] WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK CELECT FILTER IN (B)(6) 2006." 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
    615346 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening