BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    MDR report key: 1051851 · Received May 22, 2008

    Report

    Report Number
    6000002-2008-07298
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    August 24, 2007
    Report Date
    October 25, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED AT IMPLANT DUE TO WRONG SIZE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING REPLACEMENT HEART VALVE KRH EDWARDS LIFESCIENCES 4450 07F162

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention