BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1344082 · Received March 13, 2009

    Report

    Report Number
    1063481-2009-00005
    Event Type
    Other
    Date Received
    March 13, 2009
    Report Date
    March 13, 2009
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE JOURNAL ARTICLE, 'ACUTE PSEUDO-PERICARDIAL TAMPONADE': THE COMPRESSION OF THE THORACAL INFERIOR VENA CAVA- A CASE REPORT, DESCRIBES A CASE OF A (B) (6) WOMAN WHICH WAS ADMITTED TO THE HOSPITAL FOR MITRAL VALVE REPLACEMENT (MVR). AN ACUTE COMPRESSION OF THE VENA CAVA INFERIOR DEVELOPED AFTER REPAIR OF LACERATED ATRIO-CAVAL JUNCTION WITH BIOGLUE. REMOVAL OF THE BIOGLUE RELIEVED THE UNEXPECTED PROBLEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention