BEUDAMED
    FDA Adverse Event Other Summary report: N

    EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

    MDR report key: 1014103 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06198
    Event Type
    Other
    Date Received
    March 12, 2008
    Report Date
    February 19, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED. THE DATE AND THE REASON FOR THE EXPLANT IS UNK, AS NO OTHER INFORMATION WAS PROVIDED. REPORTEDLY, THE DEVICE WAS IMPLANTED IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4900T30 6L0602

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention