BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388179 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00005
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    October 29, 2001
    Report Date
    March 15, 2002
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOSCOPIC SINUS SURGERY (SEPTOPLASTY, OUTFRACTURE MIDDLE TURBINATES, ETHMOIDECTOMY, MAXILLARY ANTROSTOMIES) IN 2001. THE SURGEON USED FLOSEAL DURING THIS PROCEDURE TO ACHIEVE HEMOSTASIS. ROLLED GELATIN FILMS (STENTS) WERE PLACED IN THE SINUSES AND THE PT WAS IRRIGATED BEFORE RECOVERY. TISSUE WAS HEALING WELL AT FOLLOW-UP EVAL AT POST-OP DAY 7. AT POST-OP DAY 28, THERE WAS MODERATE ERYTHEMA, SWELLING AND SOME GREEN DRAINAGE. ANTI-INFLAMMATORY MEDICATION (REDNISONE, NASACORT SPRAY) AND ANTIBIOTICS (ROCEPHIN, VANTIN) WERE PRESCRIBED. THE PROBLEM IMPROVED BUT THEN RECURRED 6 WEEKS POST OP. PT UNDERWENT RE-OPERATION 3 DAYS LATER, AT WHICH TIME FLOSEAL WAS AGAIN USED FOR ACHIEVING HEMOSTASIS. A CULTURE OF THE NASAL AREA WAS TAKEN THIS SAME DAY AND TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS AND FUNGUS. CIPRO WAS PRESCRIBED 3 WEEKS LATER. DR REPORTED IN 2002 THAT SINUSES WERE WELL HEALED THROUGHOUT AND WELL MUCOSALIZED, WITH NO EVIDENCE OF CRUSTING OR INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HEMOSTATIC SEALANT STERILE HEMOSTATIC SEALANT KIT LMF FUSION MEDICAL TECHNOLOGIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR NONE REPORTED.