BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT

    MDR report key: 1033923 · Received April 24, 2008

    Report

    Report Number
    6000002-2008-06628
    Event Type
    Death
    Date Received
    April 24, 2008
    Date of Event
    January 30, 2008
    Report Date
    March 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED IN 2008, DUE TO GRAM NEGATIVE SEPSIS. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4475 R-07K1941

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death