BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1020393 · Received March 26, 2008

    Report

    Report Number
    6000002-2008-06347
    Event Type
    Death
    Date Received
    March 26, 2008
    Date of Event
    December 18, 2007
    Report Date
    February 29, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2007. 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 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 7A0106

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death