BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCUTEK LTD

    MDR report key: 1347381 · Received March 19, 2009

    Report

    Report Number
    MW5010420
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    March 9, 2009
    Report Date
    March 19, 2009
    Manufacturer
    VASUTEK LTD
    Product Code
    DXZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD AORTIC ROOT REPLACEMENT WITH PORCINE AORTIC VALVE REPLACEMENT IN 2008. READMITTED WITH MYCOBACTERIUM CHELONAE INFECTION OF THE GRAFT AND VALVE. BOTH THE GRAFT AND VALVE WERE REPLACED IN THE OR IN 2009. MEDTRONIC FREE STYLE AORTIC ROOT HEART VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASCUTEK LTD GELWEAVE 30MM DXZ VASUTEK LTD 85866/2A 0666

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization