BEUDAMED
    FDA Adverse Event Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1813466 · Received August 24, 2010

    Report

    Report Number
    1063481-2010-00028
    Date Received
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED AND ANY ADDITIONAL INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON STATED THAT TWO OF HIS PATIENTS THAT RECEIVED BIOGLUE IN A SURGICAL PROCEDURE DEVELOPED AN INFECTION POST - OPERATIVELY. THIS REPORT REPRESENTS THE SECOND OF THE TWO CASES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention