BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1063352 · Received June 19, 2008

    Report

    Report Number
    6000002-2008-07641
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    P980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY SYSTEM KRH EDWARDS LIFESCIENCES 4600 6E1081

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention