BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1691568 · Received May 13, 2010

    Report

    Report Number
    1063481-2010-00014
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    April 19, 2010
    Report Date
    May 13, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    OHA
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. SYNERGRAFT PULMONARY HEMI-ARTERY IS REGULATED BY THE FDA AS A DEVICE AND THEREFORE THIS REPORT IS BEING SUBMITTED TO (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BLOOD CULTURES OF THE RECIPIENT TAKEN SOME TIME AFTER IMPLANT DEVELOPED RESULTS POSITIVE FOR GRAM - NEGATIVE RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE OHA CRYOLIFE, INC. SGPH00

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DA