BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 2099757 · Received May 23, 2011

    Report

    Report Number
    2954761-2011-00035
    Event Type
    Injury
    Date Received
    May 23, 2011
    Report Date
    May 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE INSTRUCTIONS FOR USE OF FLOSEAL RECOMMEND TO ALWAYS IRRIGATE AND REMOVE ALL NON-CLOT-INVOLVED MATERIAL (EXCESS PRODUCT). THIS PUBLISHED CASE DEMONSTRATES THE POTENTIAL OUTCOME OF FLOSEAL LEFT IN PLACE AGAINST THE RECOMMENDATIONS OF THE IFU AT THE TIME OF SURGICAL PROCEDURE. RETRAINING OF THE PUBLISHING SURGEON IS NOT REQUIRED, SINCE HE IS MENTIONING THE RECOMMENDATIONS OF THE INSTRUCTIONS FOR USE AND THE VALID CONCLUSIONS OF HIS CASE REPORT. (B)(4). NO FURTHER INFORMATION IS AVAILABLE. AS THE PUBLISHING SURGEON IS AWARE OF THE RECOMMENDATIONS ON PROPER APPLICATION TECHNIQUE MENTIONED IN THE PRODUCT INSTRUCTIONS FOR USE, NO FURTHER ACTION IS NECESSARY. THIS CASE WILL BE KEPT ON RECORD FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    FROM LITERATURE: CARTER RM , HALLIWELL B, HARKINS G. PELVIC INFLAMMATORY REACTIONS TO FLOSEAL (2010). THE JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2010. DOI 10.1016/J.JMIG.2010.03.021 EVENT DESCRIPTION: A (B)(6) WOMAN UNDERWENT AN URGENT CESAREAN DELIVERY. DURING SURGERY, FLOSEAL WAS USED TO ENSURE HEMOSTASIS AFTER A POSTPARTUM HEMORRHAGE WITH UNCONTROLLABLE BLEEDING AT THE HYSTEROTOMY SITE. AFTER THE SURGERY, THE PATIENT HAD NONREMITTING PELVIC PAIN AND WAS TAKEN FOR A LAPAROSCOPY AT 6 MONTHS POSTPARTUM. DURING LAPAROSCOPY, EXTENSIVE, INFLAMMATORY DEPOSITS OF FIBRIN-LIKE MATERIAL WERE NOTED THROUGHOUT THE PELVIS, CONCENTRATED AT THE HYSTEROTOMY SITE. PATHOLOGIC EVALUATION REVEALED CALCIFICATION, FIBROSIS, NECROSIS, AND FOREIGN BODY GIANT CELL REACTION. THE FLOSEAL MANUFACTURER RECOMMENDS PLACING THE THROMBIN SOLUTION, ALLOWING TIME FOR HEMOSTASIS, THEN GENTLY IRRIGATING AND REMOVING ALL NON-CLOT-INVOLVED MATERIAL. THIS CASE DEMONSTRATES THE POTENTIAL OUTCOME OF FLOSEAL LEFT IN PLACE AT THE TIME OF SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 32 Other