BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388047 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00002
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    December 10, 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 ETHMOIDECTOMY, MAXILLARY ANTROSTOMIES, MIDDLE TURBINATE CONCHA BULOSA AND CAUTERIZATION) 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 AND SUCTIONED. AT THE 1 WEEK POSTOPERATIVE FOLLOW-UP 3 WEEKS LATER, THE PT PRESENTED WITH A SKIN INFECTION OF THE NOSE WITH LARGE AMOUNTS OF YELLOW DRAINAGE. ANTIBIOTICS WERE PRESENTED WITH A SKIN INFECTION OF THE NOSE WITH LARGE AMOUNTS OF YELLOW DRAINAGE. ANTIBIOTICS WERE PRESCRIBED. ONE WEEK LATER DRYNESS AND CRUSTING WAS OBSERVED, BUT NO THICK YELLOW DRAINAGE. ANTIBIOTICS WERE PRESCRIBED. THE NOSTRILS WERE CULTURED AND TESTED POSITIVE FOR E. COLI. 12 DAYS LATER, CIPRO WAS PRESCRIBED (500 MG B.I.D) FOR 12 DAYS. TWO DAYS LATER THE SURGEON REPORTED RECURRENCE OF THE THICK DRAINAGE. MORE ANTIBIOTICS WERE PRESCRIBED 8 DAYS LATER (VANTIN, 200MG B.I.D./10 DAYS). FOLLOW-UP 17 DAYS LATER SHOWED WELL-HEALED SINUSES AND NO INFECTION.

    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 50 YR Required Intervention NONE REPORTED.