BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5754082 · Received June 28, 2016

    Report

    Report Number
    3002808486-2016-00637
    Event Type
    Injury
    Date Received
    June 28, 2016
    Report Date
    June 16, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AGE/DATE OF BIRTH) UNKNOWN AS INFORMATION WAS NOT PROVIDED. WEIGHT) UNKNOWN AS INFORMATION WAS NOT PROVIDED. DATE OF EVENT) UNKNOWN AS INFORMATION WAS NOT PROVIDED. UNKNOWN AS INFORMATION WAS NOT PROVIDED. LOT#: UNKNOWN AS INFORMATION WAS NOT PROVIDED. CATALOG # UNKNOWN AS INFORMATION WAS NOT PROVIDED BUT REFERRED TO AN UNKNOWN IVC FILTER. EXPIRATION DATE: UNKNOWN AS LOT# IS UNKNOWN. IMPLANT DATE) UNKNOWN AS INFORMATION WAS NOT PROVIDED. SINCE CATALOG# IS UNKNOWN THE 510(K) COULD BE EITHER K000855, K032426, K061815 OR K073374. DEVICE MANUFACTURE 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] RECEIVED AN UNKNOWN IVC FILTER IN (B)(6) 2008 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
    409216 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening