BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 3853513 · Received April 3, 2014

    Report

    Report Number
    3002808486-2014-00009
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K070410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: "THEY WERE RETRIEVING THE FILTER. ON THE SCOUT IMAGE, THEY ONLY SAW 3 OF THE PRIMARY CELECT FILTER LIMBS. THE 4TH LIMB WAS VISIBLE ON THE IMPLANT DATE ((B)(6) 2009). THEY RETRIEVED FILTER AND THE 4TH LIMB WAS NOT ON THE ACTUAL FILTER ITSELF. THEY LOOKED FOR IT WITH A CT SCAN AND IT WAS NOT VISIBLE IN THE CHEST, ABDOMEN OR PELVIS AREAS. THEY BELIEVED THE PATIENT PASSED IT AT ONE POINT OR ANOTHER." PATIENT OUTCOME: AS FAR AS THE CUSTOMER CAN TELL, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200631 UNKNOWN DTK: FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR