BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1040254 · Received May 7, 2008

    Report

    Report Number
    6000002-2008-07079
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    November 28, 2007
    Report Date
    December 15, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED; HOWEVER, THE EXPLANT REASON IS UNK. NO FURTHER 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 R06M0784

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention