BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARPENTIER-EDWARDS PORCINE MITRAL VALVE SIZE 25

    MDR report key: 2113276 · Received May 17, 2011

    Report

    Report Number
    MW5020819
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 21, 2011
    Manufacturer
    JOHNSON AND JOHNSON
    Product Code
    DYE
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRESENTED FOR AND HAD MVR COMPLETED. PHYSICIAN REQUESTED CARPENTIER-EDWARDS PORCINE MITRAL VALVE SIZE 25. THE VALVE BOX, CONTAINER THE VALVE WAS IN, AND THE PAPER WORK ALL VERIFIED PORCINE VALVE. HOWEVER, THE IMPLANT PAPERS -THE ONE TO SEND TO THE COMPANY, SAID CARPENTIER EDWARDS MITRAL BIOPROTHESIS. THE OTHER IMPLANT STICKERS AND THE PT TEMPORARY CARD STATED PERICARDIAL VALVE (NOT PORCINE). STAFF MADE CORRECTIONS TO ALL PAPERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PORCINE MITRAL VALVE SIZE 25 PORCINE MITRAL VALVE DYE JOHNSON AND JOHNSON 2736090

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR