BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VESSEL CANNULAE BULK

    MDR report key: 901876 · Received August 21, 2007

    Report

    Report Number
    6000002-2007-50680
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    October 17, 2006
    Report Date
    August 14, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE PIERCED THE PT'S ARTERY DURING USE. AT THIS TIME NOT SURE IF THERE WAS PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESSEL CANNULAE BULK CANNULAE DWF EDWARDS LIFESCIENCES RESEARCH MEDICAL VSL009B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR