BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1823576 · Received September 2, 2010

    Report

    Report Number
    1063481-2010-00033
    Event Type
    Injury
    Date Received
    September 2, 2010
    Report Date
    September 2, 2010
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P010003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT THE SURGEON PERFORMED A NUMBER OF LUNG DECORTICATION PROCEDURES, SOME OF WHICH INVOLVED THE USE OF BIOGLUE. THE SURGEON INDICATED THAT THERE WERE ONE OR TWO INFECTIONS BUT COULD NOT DETERMINE IF THE INFECTIONS OCCURRED IN PATIENTS WHO HAD RECEIVED BIOGLUE. THEREFORE, IT IS NOT CLEAR IF THE REPORTED ADVERSE EVENTS ARE ASSOCIATED WITH THE USE OF BIOGLUE. NO DEFICIENCY REGARDING BIOGLUE WAS ALLEGED. FURTHERMORE, NO LOT NUMBERS OR SAMPLES WERE PROVIDED BY THE COMPLAINANT. THEREFORE, A REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED. THE USE OF BIOGLUE IN LUNG DECORTICATION PROCEDURES IS NOT AN APPROVED INDICATION IN THE UNITED STATES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SURGEON INDICATED THAT HE HAD A CASE OR TWO, IN THE LAST FEW YEARS, IN WHICH HE USED BIOGLUE AND THE PATIENT LATER DEVELOPED AN INFECTION.

    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