BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTION ELITE IVC FILTER

    MDR report key: 15310871 · Received August 26, 2022

    Report

    Report Number
    MW5111740
    Event Type
    Injury
    Date Received
    August 26, 2022
    Date of Event
    August 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    MEDICAL DEVICES INC.
    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

    OPTION ELITE IVC FILTER FOUND TO BE MULTIPLY FRACTURED. REMOVED FILTER AND FRACTURED FRAGMENT RETAINED LOCALLY WITH FORCEPS. FDA SAFETY REPORT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147306 OPTION ELITE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention| O| L