BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL MATRIX HEMOSTATIC SEALANT

    MDR report key: 427856 · Received November 13, 2002

    Report

    Report Number
    2954761-2002-00010
    Event Type
    Injury
    Date Received
    November 13, 2002
    Date of Event
    August 11, 2002
    Report Date
    October 17, 2002
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    LMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT UNDERWENT LAPAROSCOPIC SURGERY IN 2002 FOR RENAL TUMOR RESECTION. FLOSEAL WAS USED INTRAOPERATIVELY TO CONTROL BLEEDING. TWO KITS OF FLOSEAL WERE USED AND WERE APPLIED LAPAROSCOPICALLY. THIS WAS THIS SURGEON'S FIRST TIME USING FLO-SEAL. PT WAS DISCHARGED THE NEXT DAY WITHOUT RESERVATION. PT WAS RE-HOSPITALIZED POST-OP DAY 3 WITH BLEEDING FROM THE EXCISION SITE. A RETROGRADE PYELOGRAM WAS PERFORMED AND INTERMITTENT EXTRA- AND INTRA-RENAL BLEEDING AND HYDRONEPHROSIS WERE IDENTIFIED, WITH CLOTS IN THE URETER. BLEEDING FROM THE LOWER POLE (INTERLOBULAR ARTERY) WAS IDENTIFIED. THE PT WAS TREATED FOR SECONDARY BLEEDING AFTER PARTIAL RENAL RESECTION ON THE 4TH DAY POSTOPERATIVELY. A DJ STENT (CATHETER) WAS PLACED FOR DRAINAGE. CONSERVATION CARE WAS PRESCRIBED. ANGIOPLASTY WAS PERFORMED 4 WEEKS LATER; NO BLEEDING WAS OBSERVED. AS OF NOVEMBER 2002, THE PT WAS DOING FINE. THE SURGEON REPORTED THAT THE BLEEDING ENCOUNTERED INTRAOPERATIVELY COULD HAVE BEEN TREATED WITH SUTURES DIRECTLY DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOSEAL MATRIX HEMOSTATIC SEALANT STERILE HEMOSTATIC KIT LMF BAXTER HEALTHCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention