BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING WITH DURAFLO TREATMENT

    MDR report key: 1002999 · Received February 21, 2008

    Report

    Report Number
    6000002-2008-06080
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    December 3, 2007
    Report Date
    January 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY THIS DEVICE WAS EXPLANTED AFTER APPROXIMATELY 0 MONTHS DUE TO UNK REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING WITH DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4525 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention