BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1013135 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06191
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EVAL IN PROCESS, WILL PROVIDE FOLLOW-UP.

    Description of Event or Problem · 1

    REPORTEDLY, A RING WAS EXPLANTED AFTER APPROX ONE MONTH DUE TO MITRAL REGURGITATION AND CAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention