BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 2135634 · Received January 7, 2008

    Report

    Report Number
    2135634
    Event Type
    Injury
    Date Received
    January 7, 2008
    Date of Event
    November 13, 2007
    Report Date
    January 4, 2008
    Manufacturer
    BAXTER
    Product Code
    LMF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6), 2007: DIAGNOSTIC LAPAROSCOPY WITH EXTENSIVE ADHESIOLYSIS AND LEFT OVARIAN CYSTECTOMY. FLOSEAL APPLIED TO "LARGE RAW SURFACES" AND TO BLEEDING AREA LEFT PELVIC SIDEWALL BENEATH LEFT OVARY. ON (B)(6) 2007: SEEN IN OFFICE - EXTENSIVE LOWER ABDOMINAL AND LABIAL ECCHYMOSIS CONSISTENT WITH SUBCUTANEOUS BLEEDING. PT REPORTED HER DOG JUMPED ON HER LOWER ABDOMEN THE DAY AFTER SURGERY. ON (B)(6) 2007: SEEN FOR FEVER AND INCREASINGLY SEVERE LLQ PAIN. CT SHOWED APPROXIMATE 2-2.5 CM SUSPICIOUS AREA IN LEFT OVARIAN REGION CONSISTENT WITH ABSCESS OR HEMATOMA. ADMITTED TO HOSPITAL FOR IV ANTIBIOTIC THERAPY. DISCHARGED (B)(6) 2007. ON (B)(6) 2007: SEEN FOR INCREASINGLY SEVERE PELVIC AND LEFT ABDOMINAL AND LLQ PAIN; N/V, NO BM FOR SOME DAYS, ABDOMEN DISTENDED, TENDER. CT SHOWED INCREASING SIZE OF AREA PREVIOUSLY NOTED, AS WELL AS SOME OTHER AREAS SUGGESTIVE OF ABSCESS. EXAM UNDER ANESTHESIA, LEFT SALPINGO-OOPHORECTOMY. SEROSANGUINOUS FLUID W/O PUS. SIGMOID COLON DENSELY ADHERENT TO LEFT PELVIC SIDEWALL AND SOMEWHAT TO ANTERIOR ASPECT OF ABD. WALL, TOTALLY COVERING LEFT OVARY. PATHOLOGY FINDINGS INCLUDED SURFACE FOREIGN MATERIAL, GRANULATION TISSUE, EOSINOPHIL CHRONIC INFLAMMATION, OCCASIONAL MULTINUCLEATED GIANT CELLS AND FOCAL AREAS OF NECROSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention| S