BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HVTUNKNOWN

    MDR report key: 1013136 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06192
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, VALVE WAS EXPLANTED DUE TO STENOSIS. VALVE IS A 29MM, THE MODEL AND SERIAL ARE UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention