BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESEP OLIGON OXIMETRY CATHETER

    MDR report key: 2475321 · Received February 27, 2012

    Report

    Report Number
    MW5024458
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    February 11, 2012
    Report Date
    February 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    DQE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRESEP CATHETER NOTED LEAKING CLEAR FLUIDS. IV DC'D AND MFR NOTIFIED. DATES OF USE: (B)(6) 2012. REASON FOR USE: OXYMETRY MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESEP OLIGON OXIMETRY CATHETER PRESEP CATHETER DQE EDWARDS LIFESCIENCES LLC #XA3816HKSAF

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Disability