BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMUM

    MDR report key: 1852886 · Received September 29, 2010

    Report

    Report Number
    MW5017620
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MULTIPLE INTRODUCERS WERE THROWN AWAY DURING PROCEDURE DUE TO BLOOD LEAKING OUT OF PORT WHEN GUIDE WIRE WAS INTRODUCED AND WOULD NOT SEAL. BOXES WITH EXACT LOT NUMBERS WERE REMOVED FROM SHELF AND RETURNED TO REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTIMUM HEMOSTASIS INTRODUCER DYB ST JUDE MEDICAL 3143281

    Patients

    Seq Age Sex Outcome Treatment
    1 NA