BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    MDR report key: 1100805 · Received August 6, 2008

    Report

    Report Number
    6000002-2008-08350
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    June 23, 2008
    Report Date
    July 15, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, AFTER AN IMPLANT DURATION OF 14 MONTHS, DUE TO MITRAL REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R-07C0609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention