BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 5002797 · Received August 14, 2015

    Report

    Report Number
    3002808486-2015-00094
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    May 29, 2012
    Report Date
    June 28, 2017
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE: (B)(4). CATALOG NUMBER: UNKNOWN BUT REFERRED TO AS A COOK CELECT FILTER. SINCE CATALOG NUMBER IS UNKNOWN THE 510(K) COULD BE EITHER K073374, K061815, K090140, K112119, K121057 OR K121629. INVESTIGATION IS STILL IN PROGRESS. (B)(4).

    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) 2012 AT (B)(6) HOSPITAL, (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
    538466 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male