BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2490138 · Received March 13, 2012

    Report

    Report Number
    1063481-2012-00010
    Event Type
    Injury
    Date Received
    March 13, 2012
    Report Date
    May 4, 2012
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MUQ
    PMA / PMN Number
    P01003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    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, THREE PATIENTS HAVE RECENTLY PRESENTED WITH STERILE ABSCESS FROM THE ANASTOMOSES WHERE BIOGLUE WAS APPLIED. THE BIOGLUE (LOT NUMBERS NOT SPECIFIED) WAS USED IN THESE CASES DURING (B)(6) 2011. THE CASES INCLUDED TWO AORTIC ROOT REPLACEMENTS AND ONE CANNULATION SITE. THE PATIENTS RANGED IN AGE (B)(6). IN TWO OF THE CASES THE ONLY OTHER PRODUCT USED WAS FELT ON THE ANASTOMOSIS. ADDITIONAL PRODUCTS WERE UTILIZED IN THE THIRD CASE. AS SUCH, AN INVESTIGATION WAS PERFORMED. NUMEROUS ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION FROM THE SURGEON. ADDITIONALLY, INFORMATION WAS REQUESTED FROM THE SURGICAL FACILITY. HOWEVER, NO FURTHER DETAILS WERE PROVIDED. THEREFORE, A MANUFACTURING REVIEW WAS PERFORMED ON ALL LOTS OF BIOGLUE SENT TO THE HOSPITAL SIX MONTHS PRIOR TO THE EVENT. THIS REVIEW CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL PHYSICAL, FUNCTION, MICROBIAL, AND CHEMICAL SPECIFICATIONS PER THE DEVICE MASTER RECORDS. WITH THE AVAILABLE INFORMATION, NO CONCLUSIONS CAN BE MADE. 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, BIOGLUE WAS USED DURING SURGERY IN (B)(6) 2011 AND THE PATIENT HAS RECENTLY PRESENTED WITH A STERILE ABSCESS FROM THE ANASTOMOSIS WHERE THE BIOGLUE WAS APPLIED. THIS REPORT REPRESENTS ONE OF THREE CASES REPORTED AND INVOLVED EITHER AN AORTIC ROOT REPLACEMENT OR APPLICATION TO A CANNULATION SITE. THE PATIENT'S AGE RANGED FROM (B)(6). IN TWO OF THE CASES REPORTED, BOTH BIOGLUE AND FELT WERE USED ON THE ANASTOMOSIS. IN THE THIRD CASE, THE SURGEON USED OTHER PRODUCTS AS WELL.

    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