BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO-ANNULOPLASTY RING

    MDR report key: 1062585 · Received June 17, 2008

    Report

    Report Number
    6000002-2008-07584
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    April 21, 2008
    Report Date
    May 15, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008 AFTER AN IMPLANT DURATION OF 1 MONTH DUE TO AN UNKNOWN REASON. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO-ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4450 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention