BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1181642 · Received September 29, 2008

    Report

    Report Number
    6000002-2008-08803
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, WHEN THE HEART VALVE WAS IMPLANTED, THE SURGEON WAS NOT HAPPY WITH THE COAPTATION OF THE LEAFLETS. NO FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES HVTUNKNOWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK