BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX

    MDR report key: 3888323 · Received May 29, 2014

    Report

    Report Number
    3888323
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CORMATRIX CARDIOVASCULAR, INC.
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MITRAL VALVE REPLACED WITH CORMATRIX PATCH PLACED THE END OF LAST YEAR. THE PATIENT RETURNED TO THE OR FIVE MONTHS LATER FOR SEVERE RECURRENT MITRAL REGURGITATION. DEHISCENCE OF PATCH WAS NOTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317313 CORMATRIX PATCH, PLEDGET, INTRACARDIAC DXZ CORMATRIX CARDIOVASCULAR, INC. * M13K1089

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR