BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 399932 · Received June 17, 2002

    Report

    Report Number
    2954761-2002-00007
    Event Type
    Injury
    Date Received
    June 17, 2002
    Date of Event
    April 16, 2002
    Report Date
    May 14, 2002
    Manufacturer
    FUSION MEDICAL TECHNOLOGIES, INC.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A TOTAL THYROIDECTOMY FOR FOLLICULAR CARCINOMA IN 2002. FOLLOWING SURGERY, THE PATIENT DEVELOPED A HEMATOMA AT THE SURGICAL SITE. THE VOLUME OF FLUID COLLECTED AT THE SITE CAUSED THE PATIENT'S TRACHEA TO COLLAPSE, CAUSING OBSTRUCTED AIRFLOW. THE PATIENT CODED. A TRACHEOTOMY WAS REQUIRED AND THE HEMATOMA WAS EVACUATED. FLOSEAL WAS USED TO ACHIEVE HEMOSTASIS DURING THE INITIAL PROCEDURE. THE SURGEON NOTED DURING THE TRACHEOTOMY PROCEDURE THAT THE DRAIN PLACED IN THE PATIENT HAD BEEN BLOCKED BY FLOSEAL GRANULES. FOLLOWING INTERVENTION TO RELIEVE THE AIRWAY OBSTRUCTION, THE PATIENT RECOVERED WITH NO LONG-TERM ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HEMOSTATIC SEALANT STERILE HEMOSTATIC KIT LMF FUSION MEDICAL TECHNOLOGIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R NONE REPORTED.