BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 9546155 · Received January 3, 2020

    Report

    Report Number
    1416980-2020-00002
    Event Type
    Injury
    Date Received
    January 3, 2020
    Report Date
    January 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HEMOSTATIC THROMBIN-GELATIN MATRIX-RELATED INTRACRANIAL CYST FORMATION. HO M.-Y., YANG S.-H., CHEN CHIEN-MIN, ORCID: HTTP://ORCID.ORG/0000-0002-8331-8588 INSTITUTION, HUANG A.P.-H. EMBASE. WORLD NEUROSURGERY. 126 (PP 475-480), 2019. DATE OF PUBLICATION: JUNE 2019. AN: 2001814718. DIVISION OF NEUROSURGERY, DEPARTMENT OF SURGERY, NATIONAL TAIWAN UNIVERSITY HOSPITAL, ZHONGZHENG DISTRICT, TAIPEI CITY, TAIWAN (ROC). ELECTRONIC ADDRESS: [email protected]. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CATALOGUE AND LOT NUMBER UPDATED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 · 1

    A PATIENT UNDERWENT A CRANIOTOMY PROCEDURE TO DECOMPRESS THE TISSUE AND ARREST BLEEDING FROM A SUBDURAL HEMATOMA IN WHICH FLOSEAL WAS USED. IT WAS REPORTED FLOSEAL WAS USED THE INTRACRANIAL HEMORRHAGIC AREA. TEN DAYS¿ POST-OPERATIVE, A FOLLOW UP COMPUTED TOMOGRAPHY (CT) WAS PERFORMED WHICH SHOWED A STERILE CYST FORMATION. IT WAS REPORTED A CRANIOPLASTY WAS PERFORMED FOR CYST DRAINAGE. AT THE TIME OF THIS REPORT NO FURTHER DETAIL WAS PROVIDED REGARDING ADDITIONAL TREATMENT, INTERVENTIONS FOR THE EVENT OR THE PATIENT¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8129 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION NA HA160728

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention