BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1000974 · Received February 18, 2008

    Report

    Report Number
    6000002-2008-06058
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    December 28, 2007
    Report Date
    January 30, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THIS DEVICE WAS EXPLANTED AFTER APPROXIMATELY 3 MONTHS DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 324934

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention