BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR STENTED PORCINE HEART VALVE

    MDR report key: 2230856 · Received August 26, 2011

    Report

    Report Number
    3001743903-2011-00057
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE 21 MM VALVE WAS EXPLANTED DUE TO SEVERE REGURGITATION. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOR STENTED PORCINE HEART VALVE STENTED TISSUE VALVE DYE ST. JUDE MEDICAL BRASIL LTDA. 10-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R