BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 5693771 · Received June 2, 2016

    Report

    Report Number
    3002808486-2016-00373
    Event Type
    Injury
    Date Received
    June 2, 2016
    Report Date
    May 27, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN AS INFORMATION WAS NOT PROVIDED. BRAND NAME: UNKNOWN AS INFORMATION WAS NOT PROVIDED./ LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. IMPLANTED IN (B)(6) 2007. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855 OR K032426. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    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. COOK INC. WILL HANDLE THIS EVENT UNDER REFERENCE# 1820334-2016-00846 FOR ALL FUTURE REPORTS TO FDA. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK GÜNTHER TULIP FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. IMPLANT DATE: IMPLANTED IN (B)(6) 2007. PMA 510(K): SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855 OR K032426. MFG 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 SEVERAL COOK CELECT FILTERS AND GUNTHER TULIP FILTERS IN (B)(6) 2007 AT (B)(6) MEDICAL CENTER IN (B)(6)." 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 SEVERAL COOK CELECT FILTERS AND GUNTHER TULIP FILTERS IN (B)(6) 2007." 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
    349169 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O