BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388393 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00001
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    November 5, 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 (BILATERAL ENDOSCOPIC ANTERIOR ETHMOIDECTOMY, BILATERAL ENDOSCOPIC MAXILLARY ANTROSTOMIES) IN 2001. THE SURGEON USED FLOSEAL DURING THIS PROCEDURE TO ACHIEVE HEMOSTASIS. ROLLED GELATIN FILMS (STENTS) WERE PLACED IN BOTH SINUSES. DURING A 1-WEEK POSTOPERATIVE FOLLOW-UP VISIT IN 2001, THE PT COMPLAINED OF PROGRESSIVE PRESSURE AND IRRITATION. A MODERATE AMOUNT OF DEBRIS AND STENT PLACEMENT REQUIRED DEBRIDEMENT. PT WAS PRESCRIBED ANTIBIOTICS (LEVAQUIN 500MG/DAY FOR 8 DAYS) AND WAS ADVISED TO CONTINUE TO IRRIGATE REGULARLY WITH NASAL SPRAY. ONE WEEK LATER THE PT RETURNED FOR A SECOND FOLLOW-UP AND PRESENTED WITH IRRITATION AND SWELLING OF THE SINUS MEMBRANES. ANTIBIOTIC THERAPY WAS SWITCHED TO AUGMENTIN (875 MG B.I.D.). IN 2002, NO MAJOR INFLAMMATION WAS OBSERVED; SOME MUCUS BUT NO ERYTHEMA. THE PT COMPLAINED OF EAR BLOCKAGE AT THIS TIME.

    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 33 YR Required Intervention NONE REPORTED.