BEUDAMED
    FDA Adverse Event Other Summary report: N

    GEOFORM ANNULOPLASTY RING MITRAL

    MDR report key: 1023784 · Received March 18, 2008

    Report

    Report Number
    6000002-2008-06255
    Event Type
    Other
    Date Received
    March 18, 2008
    Report Date
    February 27, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 DUE TO AN UNKNOWN REASON. REPORTEDLY, THE DEVICE WAS IMPLANTED IN 2008. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEOFORM ANNULOPLASTY RING MITRAL ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4200 7D0788

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention