BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5044136 · Received September 1, 2015

    Report

    Report Number
    3002808486-2015-00100
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    May 29, 2015
    Report Date
    August 3, 2017
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE: (B)(4). SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K061815 OR K073374 OR K090140. INVESTIGATION IS STILL IN PROGRESS. MANUFACTURER REFERENCE: (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) 2009 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
    577943 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Life Threatening