BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARPENTIER - EDWARDS BIOPROSTHESIS

    MDR report key: 3177626 · Received June 13, 2008

    Report

    Report Number
    6000002-2007-05739
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    October 2, 2007
    Report Date
    October 17, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN.

    Description of Event or Problem · 1

    REPORTEDLY THIS DEVICE WAS EXPLANTED AFTER APPROXIMATELY 140 MONTHS DUE TO UNKNOWN REASONS, FROM IPR NO LETTER REQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER - EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 262525MM TBD

    Patients

    Seq Age Sex Outcome Treatment
    1