BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELECT IVC FILTER

    MDR report key: 10263437 · Received July 10, 2020

    Report

    Report Number
    MW5095485
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    July 8, 2020
    Report Date
    July 8, 2020
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CELECT IVCF FOUND TO BE MULTIPLY FRACTURED (ARMS) WITH ONE FRAGMENT LOCALLY RETAINED IN EXTRAVASCULAR POSITION, ONE FRAGMENT IN LINGULAR PULMONARY ARTERY. REMOVED FILTER AND LUNG FRAGMENT; OTHER EXTRAVASCULAR AND INACCESSIBLE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722376 CELECT IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R