BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEALANT BIOGLUE 5ML

    MDR report key: 1598390 · Received January 27, 2010

    Report

    Report Number
    1598390
    Event Type
    Death
    Date Received
    January 27, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 25, 2010
    Manufacturer
    CRYOLIFE
    Product Code
    MUQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD URGENT SURGERY (B) (6) 2009 FOR AORTIC ASCENDING THORACIC ANEURYSM. PT EXPIRED (B) (6) 2009. DEATH SUMMARY STATES: MULTI-SYSTEM ORGAN FAILURE DUE TO SEPSIS. SOURCE OF SEPSIS FELT TO BE WOUND OF SURGICAL/MEDIASTINUM AND PNEUMONIA. HOSPITAL DID AN RCA (ROOT CAUSE ANALYSIS) AND THERE WERE TWO (2) DEVICES THAT CAME UP SUSPECT. ONE WAS THE SEALANT BIOGLUE 5ML, LOT#S 09MUCV007, 09MUV008, 09SJV038, 09SJV051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEALANT BIOGLUE 5ML SEALANT BIOGLUE 5ML MUQ CRYOLIFE BG3515-5-US UNDER EVENT OR PROB

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death