BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE IVC FILTER

    MDR report key: 19751249 · Received July 15, 2024

    Report

    Report Number
    MW5157299
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 11, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPTEASE FILTER FOUND TO BE MULTIPLY FRACTURED. FILTER AND ALL BUT ONE SMALL EXTRAVASCULAR FRAGMENT REMOVED. OF NOTE, FILTER WAS INSERTED UPSIDE-DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748106 OPTEASE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention| L