BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 542115 · Received September 1, 2004

    Report

    Report Number
    6000002-2004-00239
    Event Type
    Injury
    Date Received
    September 1, 2004
    Date of Event
    September 24, 2003
    Report Date
    August 4, 2004
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED AS RING (BAND) EXPLANTED AFTER 4 YEARS DUET O AN UNKNOWN REASON. NO FURTHER INFO WAS PROVIDED. DUE TO CONFIDENTIALITY OF PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 460026MM 9G0918

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention AORTIC VALVE REPLACEMENT, 2003.