BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388603 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00004
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    November 16, 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, 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 AND SUCTIONED. THERE WAS NO INFECTION REPORTED AT FOLLOW-UP EVALUATIONS AT DAY 10 AND DAY 24 (2001). NEARLY SIX (6) WEEKS AFTER THE SURGERY, THE PT REPORTED THICK WHITE DRAINAGE UPON EVAL. THE DISCHARGE WAS RELATIVELY CLEAR AND THERE WAS NO EVIDENCE OF INFLAMMATORY DAMAGE. THIS CONTINUED UNTIL 2002, WHEN A NASAL CULTURE WAS TAKEN. THE CULTURE TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS. ANTIBIOTICS WERE PRESCRIBED 2 MOS LATER (LEVAQUIN 500 MG FOR 12 DAYS). CIPRO (500 MG B.I.D.) WAS THEN PRESCRIBED 3 DAYS LATER. PROBLEM CONTINUED AT THE LAST FOLLOW-UP EVAL THE NEXT MONTH.

    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 70 YR Required Intervention NONE REPORTED.