BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 4619465 · Received March 17, 2015

    Report

    Report Number
    3002808486-2015-00020
    Event Type
    Malfunction
    Date Received
    March 17, 2015
    Date of Event
    August 13, 2012
    Report Date
    August 29, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG# UNK BUT REFERRED TO AS A GUNTHER TULIP VENA CAVA FILTER. EXPIRATION DATE: UNK AS LOT# IS UNK. CATALOG# IS UNK THE 510(K) COULD BE EITHER K090140, K112119 OR K121057 BASED ON THE DATE OF IMPLANT. INVESTIGATION STILL IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO SHORT FORM COMPLAINT FILED: IT IS ALLEGED THAT "[PT] HAD A GUNTHER TULIP VENA CAVA FILTER IMPLANTED ON (B)(6) 2012 AT (B)(6) BY IMPLANTING SURGEON (B)(6)." PT OUTCOME: IT IS ALLEGED THAT "[PT] SUFFERED PUNITIVE DAMAGES." ADDITIONAL INFO REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182936 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening