BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 18946861 · Received March 20, 2024

    Report

    Report Number
    1416980-2024-01241
    Event Type
    Injury
    Date Received
    March 20, 2024
    Report Date
    March 20, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    C1: MANUFACTURER/COMPOUNDER: BAXTER HEALTHCARE - VIENNA INDUSTRIESTRASSE 67 VIENNA 1220 AUSTRIA E1: INITIAL REPORTER FACILITY NAME: (B)(6). E1: INITIAL REPORTER CITY: (B)(6). G1: DEVICE MANUFACTURER POSTAL CODE: 1220. TAMER, FATIH, YAZICI, BÜLENT, ORAL, AYLIN, AND AKGÜN, AYSEGÜL (2023). LONG-TERM INTENSE 18F-FDG UPTAKE BY THE HOMEOSTATIC MATRIX-ASSOCIATED INFLAMMATORY RESPONSE MAY MIMIC MALIGNANCY RECURRENCE. MOL IMAGING RADIONUCL THER 32, 233-236. DOI:10.4274/MIRT.GALENOS.2023.92499. H10: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ONE PATIENT UNDERWENT A RIGHT UPPER LOBECTOMY FOR LUNG ADENOCARCINOMA WHEREIN FLOSEAL WAS APPLIED TO PREVENT PULMONARY LACERATION-ASSOCIATED BLEEDING. ¿WHEN 18F-FLUORODEOXYGLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY/COMPUTED TOMOGRAPHY WAS PERFORMED FOR STAGING AFTER SURGERY, INTENSE 18F-FDG UPTAKE WAS OBSERVED IN THE CICATRICIAL FIBROTIC TISSUE IN THE OPERATION AREA, AND NO SIGNIFICANT CHANGE WAS OBSERVED IN THAT AREA DURING THE 4-YEAR FOLLOW-UP.¿ TREATMENT DETAILS AND PATIENT OUTCOME WERE NOT PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1756093 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention