BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1367626 · Received January 26, 2009

    Report

    Report Number
    1063481-2009-00001
    Event Type
    Other
    Date Received
    January 26, 2009
    Report Date
    January 23, 2009
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S INVESTIGATION INTO THE REPORTED EVENT IS ONGOING. ANY ADDITIONAL INFO WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, BIOGLUE SURGICAL ADHESIVE WAS USED ON TWO PTS THAT SUBSEQUENTLY DEVELOPED POST-OPERATIVE INFLAMMATION AFTER A BROWLIFT PROCEDURE. THIS REPORT REPRESENTS ONE OF THE TWO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MFI CRYOLIFE, INC. BG3502-5-US 08SUW015

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention