BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE, INC.

    MDR report key: 382924 · Received March 15, 2002

    Report

    Report Number
    MW1024431
    Event Type
    Injury
    Date Received
    March 15, 2002
    Date of Event
    March 15, 2002
    Report Date
    March 15, 2002
    Manufacturer
    *
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD AN AORTIC VALVE IMPLANT. MEASUREMENT 20MM X 6.0 CM IN 2001. THE PT RETURNED IN 2002 WITH A CEREBROVASCULAR ACCIDENT AND POSITIVE BLOOD CULTURES FOR STAPH EPI. THE PT WAS RELEASED AND HAS BEEN READMITTED TO THIS HOSP WITHIN THE LAST WEEK WITH CARDIAC ABSCESS AND ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE, INC. AORTIC VALVE MIE * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening CORONARY ARTERY BYPASS USING PTS OWN VESSELS.