BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOLIFE BIOGLUE SURGICAL ADHESIVE

    MDR report key: 2222058 · Received August 18, 2011

    Report

    Report Number
    MW5021825
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 18, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO OF TWO EVENTS: #2 (B)(6) 2011. PT WENT INTO SURGERY FOR RECURRENT PET POSITIVE LESION IDENTIFIED BY SURVEILLANCE. WHILE IN SURGERY THEY UNCOVERED THE ROOTS OF THE MASS AND FOUND A BIOGLUE KERNEL IN THE CENTER OF THE MASS. THERE WAS A 1 CM COLLECTION OF BIOGLUE THAT HAD NOT BEEN REABSORBED IN THE POSTERIOR GUTTER REMOTE FROM THE LUNG PARENCHYMA. ALSO SEE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOLIFE BIOGLUE SURGICAL ADHESIVE BIOGLUE MFI CRYOLIFE, INC. PO10003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other