BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER

    MDR report key: 1122168 · Received August 14, 2008

    Report

    Report Number
    6000002-2008-08424
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    May 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYG
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS COULD HAVE BEEN AN INCIDENT IF THE CATHETER COULD NOT HAVE BEEN RESHAPED WITH THE STYLET. THE CUSTOMER HAS SAID THAT IF THE HOSPITAL ONLY HAS ONE OF THESE WHICH ARE FAULTY, IT COULD PUT THE BABY'S LIFE OR "NEU".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY DILATION ATRIOSEPTOSTOMY CATHETER DILATION CATHETER DYG EDWARDS LIFESCIENCES 830705F 58442708

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN