BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1033794 · Received April 24, 2008

    Report

    Report Number
    6000002-2008-06613
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED. EXPLANT DATE AND IMPLANT DURATION IS UNKNOWN. THE REASON FOR EXPLANT IS UNKNOWN. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R-07K1903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention