BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 1353081 · Received March 30, 2009

    Report

    Report Number
    2954761-2009-00008
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    February 1, 2008
    Report Date
    March 30, 2009
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAXTER MEDICAL ASSESSMENT: A SMALL BOWEL OBSTRUCTION OCCURRED AFTER USE OF TWO KITS OF FLOSEAL (VOLUME NOT SPECIFIED) FOR CONTROL OF BLEEDING FROM A VENA CAVA INJURY. FLOSEAL HAS BEEN USED IN CONJUNCTION WITH SURGICEL FIBRILLAR. THE LOCAL FIBROSIS AND OBSTRUCTION REQUIRED RE-INTERVENTION AND RESECTION OF A SMALL SEGMENT OF THE BOWEL. IF EXCESS FLOSEAL IS NOT IRRIGATED, OR PRODUCT IS APPLIED TOO SLOW AND ALL APPLIED PRODUCT IS INCORPORATED IN THE FORMED BLOOD CLOT ("GLAZED STRAWBERRY"), RECENT INVESTIGATIONS HAVE SHOWN THAT RESIDUAL. EXCESS FLOSEAL MAY INDUCE A LOCAL TISSUE REACTION (FOREIGN BODY OR INFLAMMATORY REACTION) MAY OCCUR. A RESPECTIVE CHANGE OF THE INSTRUCTIONS FOR USE OF FLOSEAL HAS BEEN RECENTLY INITIATED AND IS ONGOING. SURGEON'S RE-EDUCATION IS RECOMMENDED (FAST APPLICATION AND APPROXIMATION, AND NEED FOR REMOVAL OF EXCESS). MD SAFETY OFFICER. THE RESPECTIVE CHANGE TO THE INSTRUCTIONS FOR USE OF FLOSEAL (NOTED ABOVE) WAS SUBMITTED TO THE FDA THROUGH A SUPPLEMENT ON 02/25/2009. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF RE-EDUCATION.

    Description of Event or Problem · 1

    FROM LITERATURE: HOBDAY, C.D., MILAM, M.R., MILAM, R.A., EUSCHER, E, BROWN, J (2009). POSTOPERATIVE SMALL BOWEL OBSTRUCTION ASSOCIATED WITH USE OF HEMOSTATIC AGENTS. JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY, 16, 224-2006. ABSTRACT: A CASE OF EARLY POSTOPERATIVE SMALL BOWEL OBSTRUCTION (SBO) AFTER INTRAOPERATIVE USE OF HEMOSTATIC AGENTS DURING LAPAROSCOPIC STAGING FOR ENDOMETRIAL CANCER IS REPORTED. A WOMAN UNDERWENT A LAPAROSCOPIC STAGING PROCEDURE FOR ENDOMETRIAL CANCER DURING WHICH HEMOSTATIC AGENTS WERE USED IN THE MANAGEMENT OF AN IATROGENIC INJURY TO THE INFERIOR VENA CAVA. THE PATIENT RETURNED ON POSTOPERATIVE DAY 6 WITH SBO AND WAS TAKEN TO THE OPERATING DEPARTMENT. SHE REQUIRED A SMALL BOWEL RESECTION IN THE SPECIFIC AREA WHERE THE HEMOSTATIC AGENTS WERE USED. PATHOLOGY SHOWED EXTENSIVE FIBROTIC CHANGES CAUSED BY A FOREIGN MATERIAL THAT WAS SUGGESTIVE OF A THROMBIN-RELATED PRODUCT. USE OF HEMOSTATIC AGENTS SHOULD BE CONSIDERED AS A CAUSE IN THE DIFFERENTIAL DIAGNOSIS OR PATIENTS WITH EARLY POSTOPERATIVE SBO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX LMF BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other JOHNSON AND JOHNSON WAS NOTIFIED| THE USE OF SURGICEL FIBRILLAR.