BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING

    MDR report key: 1151396 · Received September 4, 2008

    Report

    Report Number
    6000002-2008-08597
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K926138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 APPROXIMATELY AFTER IMPLANT DURATION OF 0.87 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO MITRAL ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 R08C0456

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention