BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOGLUE SURGICAL ADHESIVE

    MDR report key: 476148 · Received August 6, 2003

    Report

    Report Number
    1063481-2003-00082
    Event Type
    Other
    Date Received
    August 6, 2003
    Date of Event
    June 12, 2003
    Report Date
    July 7, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT OF UNKNOWN AGE AND MEDICAL HISTORY UNDERWENT SURGICAL PROCEDURE USING A TRANLABYRINTHINE APPROACH TO REMOVE AN ACOUSTIC SCHWANNOMA NOT AN APPROVED INDICATION IN THE US. THERE WERE NO EARLY POSTOPERATIVE COMPLICATIONS OR CEREBRALSPINAL FLUID (CSF) LEAKS NOTED BY THE SURGEON. 2 MONTHS LATER, THE PT REPORTED TO THE CLINIC WITH CSF RHINORRHEA. THE PT UNDERWENT REOPERATION A MONTH LATER TO REPAIR THE CSF LEAK. THE SOURCE OF THE CSF LEAK WAS THROUGH THE PETROUS TEMPORAL BONE AND INTO THE MIDDLE EAR CAVITY WHERE BIOGLUE SURGICAL ADHESIVE WAS APPLIED AS FILTER BETWEEN A FASCIA LATA PATCH AND BONE SURFACE. SUBSEQUENTLY, CSF EXITED THROUGH THE EUSTACHIAN TUBE AND INTO THE NASAL CAVITY. THE DEFECT WAS SUBSEQUENTLY REPAIRED AND THE PT HAS HAD NO FURTHER COMPLICATIONS REPORTED TO DATE.

    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 UNKNOWN Hospitalization| O| R