BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1233911 · Received November 13, 2008

    Report

    Report Number
    6000002-2008-09279
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 3, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K020864
    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 A FAILED RING REPAIR. NO FURTHER DETAILS WERE PROVIDED. INFORMATION LEARNED FROM THE OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention