BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ MONITORING "S" TIP CATHETER DOUBLE LUMEN

    MDR report key: 1122184 · Received August 15, 2008

    Report

    Report Number
    6000002-2008-08426
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON DID NOT DEFLATE BEFORE USE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ MONITORING "S" TIP CATHETER DOUBLE LUMEN MONITORING CATHETER DYG EDWARDS LIFESCIENCES, PR S111F7 58503930

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other