BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING W/DURAFLO TREATMENT

    MDR report key: 1051859 · Received May 21, 2008

    Report

    Report Number
    6000002-2008-07264
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    November 26, 2007
    Report Date
    December 14, 2007
    Manufacturer
    EDWARDS LIFESCIENCES, LLC
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO AN UNSUCCESSFUL RING REPAIR. IT IS UNK IF THE DEVICE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING W/DURAFLO TREATMENT ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES, LLC 4475 R07H1601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention