BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO

    MDR report key: 1131909 · Received August 20, 2008

    Report

    Report Number
    6000002-2008-08466
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K980487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    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 AFTER IMPLANT DURATION OF ZERO DAYS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM IMPLANT PATIENT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING WITH DURAFLO ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4475 6B0486

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGEON