BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL HEMOSTATIC MATRIX

    MDR report key: 1026404 · Received April 8, 2008

    Report

    Report Number
    2954761-2008-00022
    Event Type
    Injury
    Date Received
    April 8, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL BAXTER MEDICAL DIRECTOR ASSESSMENT: MARCH 15, 2008. FLOSEAL IS AN ADJUNCT TO HEMOSTASIS. ITS USE IN CONJUNCTION WITH OR FOR ADHESION PREVENTION IS NOT INDICATED. THE PRODUCT HAS TO BE APPLIED IN COMPLIANCE WITH THE IFU, ONLY ON ACTIVE BLEEDING SITES, AND THE EXCESS PRODUCT (NOT INCLUDED IN THE FLOSEAL - BLOOD CLOT) MUST BE REMOVED BY GENTLE IRRIGATION. THE REPORTED SYMPTOMS MAY BE RELATED TO AT LEAST ONE ERROR IN USE OF FLOSEAL: NOT REMOVING THE EXCESS OF PRODUCT. THE OTHER USER ERROR MIGHT BE THE INTENTION TO USE THE PRODUCT FOR ADHESION PREVENTION, NOT FOR HEMOSTASIS. SURGEON NEEDS ADD'L RETRAINING WHICH SPECIFIES THAT FLOSEAL HAS TO BE USED ONLY IN THE PRESENCE OF ACTIVE BLEEDING (NOT FOR ADHESION PREVENTION PURPOSES) AND IN CASE OF BLEEDING, THE EXCESS FLOSEAL HAS TO BE REMOVED BY IRRIGATION. THERE ARE NO INCONSISTENCIES OF THE IFU THAT ARE TO BE ADDRESSED. APRIL 8, 2008: ADD'L INFO CONFIRMS AN ACUTE PERITONITIS. THE USER ERROR OF NOT RINSING AWAY THE EXCESS OF PRODUCT MAY POTENTIALLY HAVE CONTRIBUTED TO THE ONSET OF THE INFLAMMATORY AND LATER INFECTIOUS REACTION, RESPECTIVELY. REPORTABILITY (US) DOES NOT CHANGE. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    DETAILS OF EVENT: PT REQUIRED RE-OPERATION DUE TO PELVIC PAIN. PT HAD DIFFUSE INFLAMMATION AT SITES OF SEPRAFILM AND FLOSEAL APPLICATION. IT WAS NOTED THAT THE SURGEON DID NOT RINSE EXCESS PRODUCT AWAY. TREATMENT OF ADVERSE EVENT: SURGICAL EXPLORATION DUE TO PAIN. RE-EDUCATION: BIOSURGERY SCIENCE LIAISON, WENT OVER THE IFU AND NEED TO RINSE AWAY EXCESS FLOSEAL AND EXPLAINED THE IFU WARNINGS AND PRECAUTIONS WITH THE SURGEON. ADD'L INFO RECEIVED ON 3/20/2008 BY BIOSURGERY SCIENCE LIAISON: HOW APPLIED: LAPAROSCOPIC APPLICATION - DID NOT RINSE AWAY/IRRIGATE EXCESS FLOSEAL EVENT DETAIL: A RETROPERITONEAL DISSECTION WITH PARTIAL OMENTECTOMY AND LEFT OOPHORECTOMY WAS PERFORMED - REPORTER STATED THAT HE LAPAROSCOPICALLY USED 5ML OF FLOSEAL AND ALSO SEPRAFILM (BY CREATING A SEPRAFILM "SLURRY''). FOLLOWING THE INITIAL SURGERY THE PT DEVELOPED SIGNS AND SYMPTOMS OF AN INFECTION AND UNDERWENT AND EXPLORATORY OPERATION AND WAS FOUND TO HAVE ACUTE PERITONITIS. REPORTER STATED HE COULD NOT FIND AN EXPLANATION FOR THE ACUTE PERITONITIS. STATUS OF PT: REPORTER STATED THAT THE PT HAS RECOVERED. RE-EDUCATION PERFORMED: REPORTER INFORMED OF THE RECOMMENDATION ON THE FLOSEAL IFU - THAT ONCE BLEEDING HAS CEASED, EXCESS PRODUCT THAT IS NOT INCORPORATED INTO THE CLOT, SHOULD BE REMOVED BY GENTLE IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL HEMOSTATIC MATRIX LMF - AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASE LMF BAXTER HEALTHCARE CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention THE OWNER OF SEPRAFILM)| SEPRAFILM (THE CASE WAS PROVIDED TO GENZYME