BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 496007 · Received November 17, 2003

    Report

    Report Number
    1063481-2003-00089
    Event Type
    Other
    Date Received
    November 17, 2003
    Date of Event
    October 17, 2003
    Report Date
    October 17, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY UNDERWENT SURGICAL PROCEDURE TO REPAIR A LARGE INFARCT AREA OF THE HEART USING PERICARDIUM AND BIOGLUE SURGICAL ADHESIVE TO SEAL THE ANASTOMOSIS. AT SOME TIME POST-SURGERY (TIME PERIOD IS UNKNWON) THE PATIENT HAD A BLOCKAGE IN ONE ARM AND THE SURGEON CLAIMED TO HAVE REMOVED BIOGLUE DURING A THROMBECTOMY PROCEDURE. ALTHOUGH REPEATED REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE, NO FURTHER INFORMATION IS CURRENTLY KNOWN ABOUT THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| O| R