BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORMATRIX ECM FOR PERICARDIAL CLOSURE

    MDR report key: 7050295 · Received November 21, 2017

    Report

    Report Number
    7050295
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    April 3, 2017
    Report Date
    November 1, 2017
    Manufacturer
    AZIYO BILOGICS
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CORMATRIX GRAFT USED TO SEAL THE ASD DEHISCED FROM THE WALL OF THE HEART CAUSING RECURRENCE OF THE ASD. PATIENT HAD TO RETURN TO OPERATING ROOM FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829483 CORMATRIX ECM FOR PERICARDIAL CLOSURE CORMATRIX DXZ AZIYO BILOGICS CMCV-060-402 M16M1286

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other