BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 1220579 · Received October 30, 2008

    Report

    Report Number
    1063481-2008-00024
    Event Type
    Other
    Date Received
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADD'L INFO WILL BE PROVIDED IN THE F/U REPORT.

    Description of Event or Problem · 1

    ACCORDING TO A "LETTER TO THE EDITOR" ENTRY IN THE JOURNAL OF DISEASES OF THE COLON AND RECTUM, SIX PTS WERE TREATED WITH COMPLEX ANORECTAL FISTULAS. IT WAS REPORTED THAT NONE OF THE PT'S FISTULAS WERE ABLE TO BE CLOSED. IN ADDITION, FOUR PTS DEVELOPED ACUTE SEPSIS AND THREE REQUIRED OPERATIVE INTERVENTION TO DRAIN THE INFECTION AND/OR DEBRIDE THE BIOGLUE. HOWEVER, THE TOTAL NUMBER OF PTS WITH ONE OR MORE COMPLICATIONS IS NOT KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other