BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORMATRIX CARDIOVASCULAR

    MDR report key: 7453673 · Received April 23, 2018

    Report

    Report Number
    MW5076646
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    October 26, 2017
    Report Date
    April 18, 2018
    Manufacturer
    AZIYO BIOLOGICS
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ANEURYSM ARISING FROM SITE OF PATCH PLACED ON (B)(6) 2017. REPAIRED WITH BOVINE PERICARDIAL PATCH. DIAGNOSIS OR REASON FOR USE: CAROTID STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294998 CORMATRIX CARDIOVASCULAR VASCULAR PATCH DXZ AZIYO BIOLOGICS CMCV-013-609 M17E110J

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention