BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2485978 · Received March 9, 2012

    Report

    Report Number
    1063481-2012-00008
    Event Type
    Injury
    Date Received
    March 9, 2012
    Report Date
    April 30, 2012
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, TWO PATIENTS EXPERIENCED INFECTION AFTER BIOGLUE USE. SIX MONTHS AFTER THE INITIAL OPERATION, A PNEUMONECTOMY WAS REQUIRED. THE PATIENT HAD EMPYEMA. ADDITIONALLY, BIOGLUE WAS FOUND TO BE "FLOATING" IN THE PATIENT'S CHEST. DESPITE NUMEROUS ATTEMPTS TO OBTAIN FURTHER INFORMATION, THE SURGEON WHO REPORTED THESE EVENTS DECLINED TO BE INVOLVED IN THE COMPLAINT PROCESS. LOT NUMBERS AND FURTHER DETAILS WERE NOT PROVIDED. ADDITIONALLY, THE DATES THE EVENTS OCCURRED ARE NOT KNOWN AND THEREFORE SHIPPING RECORDS COULD NOT BE REVIEWED TO IDENTIFY POSSIBLE LOT NUMBERS OF THE BIOGLUE INVOLVED. AT THIS TIME, THERE IS INSUFFICIENT INFORMATION AVAILABLE TO PERFORM AN INVESTIGATION OF THIS COMPLAINT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE THE COMPLAINT WILL BE REOPENED AND THE INFORMATION WILL BE EVALUATED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, TWO PATIENTS EXPERIENCED INFECTION AFTER BIOGLUE USE. SIX MONTHS AFTER THE INITIAL OPERATION, A PNEUMONECTOMY WAS REQUIRED. THE PATIENT HAD EMPYEMA. ADDITIONALLY, BIOGLUE WAS FOUND TO BE "FLOATING" IN THE PATIENT'S CHEST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other