BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 881809 · Received September 19, 2006

    Report

    Report Number
    1063481-2006-00041
    Event Type
    Malfunction
    Date Received
    September 19, 2006
    Report Date
    September 19, 2005
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS INITIATED AN INVESTIGATION THAT IS ONGOING.

    Description of Event or Problem · 1

    ACCORDING TO THE MEDWATCH REPORT DATED 09/19/2005 AND RECEIVED ON 08/24/2006, BIOGLUE WAS UTILIZED FOR A URETERIC ANASTOMOSIS ANASTOMOSIS AND LEAKS WERE OBSERVED AROUND THE ANASTOMOTIC SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGLUE SURGICAL ADHESIVE SURGICAL ADHESIVE MFI CRYOLIFE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other