BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5002798 · Received August 14, 2015

    Report

    Report Number
    3002808486-2015-00093
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    May 24, 2013
    Report Date
    July 10, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. PMA 510(K): SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815, K090140, K112119, K121059 OR K121629 MFG DATE: UNKNOWN AS LOT# IS UNKNOWN. INVESTIGATION IS STILL IN PROGRESS. (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. PMA 510(K) SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815, K090140, K112119, K121059 OR K121629. 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] WAS IMPLANTED WITH A COOK CELECT FILTER ON (B)(6) 2013 AT (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
    539102 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Life Threatening