BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1200168 · Received September 30, 2008

    Report

    Report Number
    1063481-2008-00023
    Event Type
    Other
    Date Received
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON REPORTED THAT ONE OF HIS PATIENTS EXPERIENCED A COMPLICATION AFTER UNDERGOING A BROW LIFT WITH BIOGLUE FOR FIXATION. APPROX 3 WEEKS POST OP, THE INCISIONS STARTED DRAINING A PURULENT MATERIAL AND REQUIRED REOPERATION. THE SURGEON FLUSHED AND IRRIGATED THE AREA, AND REMOVED MANY 'CRYSTALLIZED BIOGLUE PARTICLES". THE PATIENT HAS SINCE DONE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MFI CRYOLIFE, INC. BG3502-5-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention