BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 18945094 · Received March 20, 2024

    Report

    Report Number
    1416980-2024-01240
    Event Type
    Injury
    Date Received
    March 20, 2024
    Report Date
    July 9, 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: (B)(6). G1: DEVICE MANUFACTURER POSTAL CODE: (B)(4). AYDOGAN, TAHSIN BATUHAN, BINBAY, MURAT (2023). CAN A SINGLE-LAYER OF RENORRHAPHY BE APPLIED WITH HEMOSTATIC AGENT IN ROBOT ASSISTED LAPAROSCOPIC NEPHRON-SPARING SURGERY APPLIED TO COMPLEX RENAL TUMORS? YENI ÜROLOJI DERGISI - THE NEW JOURNAL OF UROLOGY, 18(1):55-61. DOI: 10.33719/YUD.2023;18-1-1191867. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: G2 AND G4. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ONE PATIENT UNDERWENT A ROBOTIC PARTIAL NEPHRECTOMY DUE TO A COMPLEX RENAL TUMOR WHEREIN FLOSEAL WAS APPLIED. AFTER AN UNSPECIFIED AMOUNT OF TIME THE PATIENT PRESENTED WITH A FEVER (NOT FURTHER SPECIFIED). UNSPECIFIED ANTIPYRETICS WERE INITIATED. PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523839 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention