BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK FILTER CELECT UNI

    MDR report key: 3893830 · Received June 18, 2014

    Report

    Report Number
    MW5036784
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 17, 2014
    Manufacturer
    COOK MEDICAL
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER APPROPRIATE POSITIONING, A CELECT FILTER WAS ADVANCED. THIS FILTER WAS UNABLE TO DEPLOY. SEVERAL ATTEMPTS AT DEPLOYMENT DID NOT RELEASE ALL OF THE TIMES. THE FILTER WAS REMOVED AND A TULIP FILTER WAS REINSERTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358918 COOK FILTER CELECT UNI IVC FILTER DTK COOK MEDICAL E2819538

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention