BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388049 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00006
    Event Type
    Injury
    Date Received
    April 12, 2002
    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, MAXILLARY ANTROSTOMIES AND TISSUE REMOVAL, FRONTAL SINUS EXPLORATION, OUTFRACTURE INFERIOR TURBINATES AND CAUTERIZATION) IN 2001. THE SURGEON USED FLOSEAL DURING THIS PROCEDURE TO ACHIEVE HEMOSTASIS. ROLLED GELATIN FILMS (STENTS) WERE PLACED IN THE SINUSES. THE FIRST FOLLOW-UP EVALUATION OCCURRED ON POST-OP DAY 14 AND INVOLVED DEBRIDEMENT OF NASAL CAVITIES AND REMOVAL OF THE STENTS (WITH DIFFICULTY). AT THE 1-MONTH FOLLOW-UP EVALUATION, PT PRESENTED WITH THICK MUCOSAL FLUID. A CULTURE WAS TAKEN AND THE RESULTS WERE POSITIVE FOR STAPHYLOCOCCUS. ANTIBIOTICS WERE PRESCRIBED (CIPRO 500 MG B.I.D.). 6 WEEKS LATER THE PT CONTINUED TO HAVE THICK MUCOSAL DISCHARGE,AND CEFTIN WAS PRESCRIBED, 500 MG B.I.D. TWO WEEKS LATER, PT STILL COMPLAINED OF THICK MUCOSAL DISCHARGE, AND REVISION SURGERY WAS BEING CONSIDERED.

    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 68 YR PRAVACHOL, ACIPHEX