BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOLIFE INC.

    MDR report key: 558052 · Received December 1, 2004

    Report

    Report Number
    558052
    Event Type
    Injury
    Date Received
    December 1, 2004
    Date of Event
    November 18, 2004
    Report Date
    November 29, 2004
    Manufacturer
    CROYOLIFE INC.
    Product Code
    MWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2004 OPERATION PERFORMED: REDO RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT, UTILIZING A 23 MM PORCINE STENTLESS VALVE, SUTURE CLOSURE OF PATENT FORAMEN OVALE, PULMONARY ALLOGRAFT PATCH ANGIOPLASTY OF RIGHT PULMONARY ARTERY. ROUTINE SMALL SAMPLE SENT TO MICROBIOLOGY LAB FOR TESTING AT TIME OF SURGERY. NEXT DAY MICROBIOLOGY TESTS RESULTS: 4 + STAPHYLOCOCCUS AUREUS METHICILLIN RESISTANT MEC A GENE DETECTED. PICU PHYSICIANS AND HOSP EPIDEMIOLOGY COODINATOR WERE NOTIFIED BY MICROBIOLOGY. THE DECISION WAS MADE TO TREAT PT FOR MRSA ENDOCARDITIS. THREE DAYS LATER REP OF CRYOLIFE CALLED AND IS INVESTIGATING THE DONOR OF TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE INC. PULMONARY ARTERY CONDUIT MWH CROYOLIFE INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R