BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1082279 · Received July 25, 2008

    Report

    Report Number
    6000002-2008-08226
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    September 5, 2007
    Report Date
    September 13, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 2007, DUE TO LEAKING UPON PLACEMENT OF THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600M28 R-07H1523

    Patients

    Seq Age Sex Outcome Treatment
    1