BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TRE

    MDR report key: 1063347 · Received June 19, 2008

    Report

    Report Number
    6000002-2008-07636
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 13, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 IMPLANTED AND EXPLANTED IN 2008, DUE TO AN UNK REASON. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO TRE ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4475 6D0808

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention