BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWAN-GANZ COMBO VIP CATHETER

    MDR report key: 909807 · Received September 4, 2007

    Report

    Report Number
    6000002-2007-51910
    Event Type
    Other
    Date Received
    September 4, 2007
    Report Date
    May 31, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: IT WAS OBSERVED THAT THE CATHETER WAS RETURNED IN ITS SEALED ORIGINAL PLASTIC POUCH. OUR INITIAL EXAMINATION DID NOT FIND ANY HAIR CONTAMINATION. HAIR PARTICULATE WAS NOT OBSERVED IN THE PACKAGING POUCH AFTER IT WAS OPENED FOR FURTHER EXAMINATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAIR WAS OBSERVED INSIDE OF THE TRAY KIT PACKAGING BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ COMBO VIP CATHETER CONTINUOUS CARDIAC OUTPUT CATHETER DXG EDWARDS LIFESCIENCES 777HF8 157AC343

    Patients

    Seq Age Sex Outcome Treatment
    1 YR