BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERICARDIAL TISSUE HEART VALVE

    MDR report key: 1000343 · Received February 7, 2008

    Report

    Report Number
    MW5005560
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 22, 2008
    Manufacturer
    EDWARD LIFE SCIENCES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD VALVE REPLACEMENT DONE IN 2002. REQUIRED REPLACEMENT OF THAT VALVE IN 2008. VALVE HAD CALCIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERICARDIAL TISSUE HEART VALVE AORTIC VALVE IMPLANT LWR EDWARD LIFE SCIENCES 27MM 2800 HC4412

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization