BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOBLUE SURGICAL ADHESIVE

    MDR report key: 761995 · Received September 19, 2006

    Report

    Report Number
    1063481-2006-00040
    Event Type
    Injury
    Date Received
    September 19, 2006
    Report Date
    September 19, 2005
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 A MEDWATCH REPORT DATED 09/19/2005, AND RECEIVED BY THE MFR ON 08/24/2006, BIOGLUE WAS UTILIZED FOR A SMALL BOWEL ANASTOMOSIS AND THE ANASTOMOSIS REPORTEDLY "FELL APART", RESULTING IN SEPSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L