BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE IVC FILTER

    MDR report key: 14601667 · Received June 3, 2022

    Report

    Report Number
    MW5110103
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 1, 2022
    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 IVC FILTER FOUND TO BE FRACTURED. FILTER WAS REMOVED TODAY, WITHOUT FURTHER FRACTURE, AND NO FRAGMENTS WERE RETAINED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2810370 OPTEASE IVC FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Life Threatening| R