BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TREATMENT

    MDR report key: 1020399 · Received March 26, 2008

    Report

    Report Number
    6000002-2008-06360
    Event Type
    Death
    Date Received
    March 26, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2008. IT IS UNK IF THE PT'S DEATH WAS ATTRIBUTED TO THE DEVICE, AS NO OTHER 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 6B0394

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death