BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1071391 · Received July 3, 2008

    Report

    Report Number
    6000002-2008-07889
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    May 26, 2008
    Report Date
    May 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K912554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY ATTACHED = APPROXIMATELY 5 CUTS WERE DETECTED IN SILICONE RUBBER OF THE RING, EACH MEASURE TO APPROXIMATELY 1MM EACH. THE CUTS ARE MOST LIKELY DUE TO MECHANICAL INJURY, AND LED TO DISRUPTIONS IN THE CLOTH OF THE SEWING RING AND THE THREAD TO UNRAVEL. THE DISRUPTED AREA IN THE CLOTH MEASURES TO APPROXIMATELY TO 8MM. NO OTHER INCONSISTENCIES DETECTED.

    Description of Event or Problem · 1

    DURING THE INITIAL SUTURE, THE RING SHOWED EXTREME FRAYING. DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4400M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention