BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1033925 · Received April 24, 2008

    Report

    Report Number
    6000002-2008-06626
    Event Type
    Death
    Date Received
    April 24, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 25, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED IN 2008, DUE TO AN UNKNOWN REASON. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 58423689

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death