BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 5298305 · Received December 15, 2015

    Report

    Report Number
    3002808486-2015-00171
    Event Type
    Injury
    Date Received
    December 15, 2015
    Report Date
    November 21, 2015
    Manufacturer
    COOK INC
    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 AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK TULIP GÜNTHER FILTER. EXPIRATION DATE UNKNOWN AS LOT # IS UNKNOWN. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K090140, K112119 OR K121057. MFR DATE UNKNOWN AS LOT # IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AS A COOK TULIP GÜNTHER FILTER. LOT# UNKNOWN AS INFORMATION WAS NOT PROVIDED. EXPIRATION DATE UNKNOWN AS LOT# IS UNKNOWN. AS CATALOG # IS UNKNOWN IT COULD BE EITHER K090140, K112119 OR K121057. INVESTIGATION IS STILL IN PROGRESS.

    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) 2013." 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 GUNTHER TULIP FILTER ON (B)(6) 2013 AT THE (B)(6) MEDICAL CENTER, (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
    827461 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening