BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEFT ARTERIAL PRESSURE MONITORING CATHETER

    MDR report key: 902531 · Received August 21, 2007

    Report

    Report Number
    6000002-2007-05060
    Event Type
    Malfunction
    Date Received
    August 21, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 9, 2007
    Manufacturer
    EDWARDS LIFESCIENCES RESEARCH MEDICAL
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MISASSEMBLY/INCOMPLETE ASSY (BONDING). IT WAS REPORTED THAT BOTH LOTS (12X 58290351, 7X 58309587) WERE MISSING SIDE HOLES. RECALL PER CAPA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEFT ARTERIAL PRESSURE MONITORING CATHETER PRESSURE MONITORING CATHETER GWM EDWARDS LIFESCIENCES RESEARCH MEDICAL LAP17 58290351

    Patients

    Seq Age Sex Outcome Treatment
    1 YR