BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6175205 · Received December 15, 2016

    Report

    Report Number
    1820334-2016-01610
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    May 8, 2016
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2016-00325 . NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. AN UPDATED EMDR REPORT WAS SUBMITTED UNDER COOK INC. MFR REPORT # 1820334-2016-00677, FOLLOW UP # 1. THIS WAS IN REFERENCE TO WILLIAM COOK (B)(4) MFR REPORT # 3002808486-2016-00325. HOWEVER, THE INITIAL FOR MFR REPORT # 1820334-2016-00677 HAD ALREADY BEEN USED ON A DIFFERENT COMPLAINT. COOK IS NOW SUBMITTING AN INITIAL REPORT UNDER MFR REPORT #1820334-2016-01610 TO CORRECT THIS ISSUE. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. (B)(4). EVALUATION- NO INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED. WE HAVE INVESTIGATED BASED ON THE INFORMATION RECEIVED TO DATE, AND ARE CLOSING THE REPORT UNTIL FURTHER INFORMATION IS RECEIVED FOR INVESTIGATION. IMPOSSIBLE TO COMMENT ON ALLEGED INJURIES. NO NOTES OF RELEVANCE ON FOUND IN THE WORK ORDER, NOR ON FILTER LOTS. NO OTHER COMPLAINTS RECEIVED UNDER THE SAME LOT. THERE IS NO EVIDENCE TO SUGGEST THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATIONS. WE HAVE NOTIFIED APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. IF ADDITIONAL INFORMATION IS RECEIVED, THE REPORT WILL BE RE-OPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] RECEIVED A COOK GUNTHER TULIP FILTER ON (B)(6) 2012 AT (B)(6) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829121 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC N/A 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other