BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALABAMA TISSUE CENTER, INC.

    MDR report key: 558373 · Received October 7, 2004

    Report

    Report Number
    MW1033593
    Event Type
    Other
    Date Received
    October 7, 2004
    Date of Event
    August 27, 2004
    Report Date
    September 10, 2004
    Manufacturer
    UNK
    Product Code
    MIE
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON CULTURED THE AORTIC VALVE BEFORE IMPLANTING INTO THE PT, AND THE VALVE GREW OUT RARE STAPHYLOCOCCUS COAGULASE NEGATIVE. THE PT HAD NO ADVERSE EFFECTS, DID NOT REQUIRE TREATMENT OR PROLONGED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALABAMA TISSUE CENTER, INC. AORTIC VALVE MIE UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other