BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 388124 · Received April 12, 2002

    Report

    Report Number
    2954761-2002-00003
    Event Type
    Injury
    Date Received
    April 12, 2002
    Date of Event
    December 12, 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, TURBINECTOMY, ETHMOIDECTOMY, MAXILLARY ARTROSTOMIES) IN 2001. THE SURGERON USED FLOSEAL DURING THIS PROCEDURE TO ACHIEVE HEMOSTASIS. ROLLED GELATIN FILMS (STENTS) WERE PLACED IN THE SINUSES AND THE PT WAS IRRIGATED AND SUCTIONED. THE PT SHOWED PROGRESSIVE HEALING AT THE NEXT FOUR (4) FOLLOW-UP VISITS ENDING 10 WEEKS POST-OP. THE RECORDED ENTRY NOTED THE SINUSES HAD HEALED THROUGHOUT. PT RETURNED WITH A COMPLAINT OF THICK YELLOW DRAINAGE 6 MONTHS LATER. PT WAS PRESCRIBED NASONEX NASAL SPRAY. THE PT HAD AN ALLERGIC REACTION TO THE MEDICATION, SO THE DOSAGE WAS REDUCED. IN 2002, PT PRESENTED WITH THICK CLUMPS OF YELLOW DRAINAGE. THE DOCTOR NOTED THE PT TO BE A HEAVY SMOKER, WHICH MAY HAVE IMPAIRED SINUS HEALING. A CULTURE WAS TAKEN. RESULTS WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. ANTIBIOTICS WERE PRESCRIBED, AND ADD'L NASAL CAVITY CULTURES WERE TAKEN 6 WEEKS LATER BECAUSE YELLOW DRAINAGE WAS STILL OBSERVED. SPECIES IDENTIFIED WERE REPORTED AS NORMAL FLORA. CLINDAMYCIN (150MG B.I.D./12 DAYS) WAS PRESCRIBED AND THE PT IS NOW SCHEDULED FOR RE-OPERATION.

    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 40 YR Required Intervention NONE REPORTED.