BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAXIAL MICRO-PUNCTURE INTRODUCER SET

    MDR report key: 1073667 · Received July 9, 2008

    Report

    Report Number
    1820334-2008-00357
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING THIS CASE, THE WIRE WAS COMPLETELY STUCK AND UNRAVELED AND THEN LODGED IN THE PT. THE PT WAS THEN TAKEN TO SURGERY AND THE REST OF THE WIRE GUIDE SUCCESSFULLY REMOVED. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAXIAL MICRO-PUNCTURE INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2063851

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention