BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTIMUM

    MDR report key: 588176 · Received March 31, 2005

    Report

    Report Number
    588176
    Event Type
    Injury
    Date Received
    March 31, 2005
    Date of Event
    February 24, 2005
    Report Date
    March 8, 2005
    Manufacturer
    ST. JUDE, DAIG DIVISION, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    S FR. LONG SHEATH INSERTED INTO PT'S RIGHT GROIN. BROKE OFF AT HUB. SURGEON WAS CONSULTED AND SHEATH WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM S FRENCH LONG SHEATH CATHETER DYB ST. JUDE, DAIG DIVISION, INC. * 03BX82

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention