BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 8350913 · Received February 19, 2019

    Report

    Report Number
    1820334-2019-00447
    Event Type
    Injury
    Date Received
    February 19, 2019
    Report Date
    March 25, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5: DURING THE MANUFACTURER¿S INVESTIGATION OF THIS COMPLAINT, IT WAS FOUND THAT THIS REPORT IS A DUPLICATE TO (B)(4). ANY ADDITIONAL INFORMATION RECEIVED, INCLUDING INVESTIGATION RESULTS, WILL BE SUBMITTED UNDER (B)(4) AND REPORT REFERENCE NUMBER (B)(4), AS THIS FILE WILL BE CLOSED-CANCELLED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. - ATTACHMENT: [JOURNAL ARTICLE BAPTISTA_SINCOS.PDF].

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    UNKNOWN GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER. OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K161218. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A REVIEW OF THE LITERATURE PUBLISHED IN PHLEBOLOGY IN 2018 REPORTS DUODENAL PERFORATION RESULTING FROM A BIRD'S NEST FILTER. THE (B)(6) YEAR OLD FEMALE PATIENT PRESENTED WITH ABDOMINAL PAIN 10 YEARS AFTER FILTER PLACEMENT FOR DEEP VEIN THROMBOSIS (DVT) AND CONTRAINDICATION TO ANTICOAGULATION THERAPY. IT IS UNKNOWN HOW THE DEVICE WAS RETRIEVED OR HOW THE PATIENT WAS TREATED FOR THE PERFORATION. CITATION: BAPTISTA SINCOS ET AL., (2018). SYMPTOMATIC DUODENAL PERFORATION BY INFERIOR VENA CAVA FILTER. PHLEBOLOGY, 33 (8), PP523-533.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142562 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening