BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 9903197 · Received March 31, 2020

    Report

    Report Number
    1416980-2020-01857
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LMF
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STUDY WAS CONDUCTED FROM (B)(6) 2013 TO (B)(6) 2017. LITERATURE ARTICLE: CHUNG JPW, LAW TSM, CHUNG CHS, MAK JSM, SAHOTA DS, LI TC. ¿IMPACT OF HAEMOSTATIC SEALANT VERSUS ELECTROCOAGULATION ON OVARIAN RESERVE AFTER LAPAROSCOPIC OVARIAN CYSTECTOMY OF OVARIAN ENDOMETRIOMAS: A RANDOMISED CONTROLLED TRIAL¿. BJOG 2019; 126:1267¿1275. DOI: 10.1111/1471-0528.15807. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: 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 · 1

    IT WAS REPORTED 94 PATIENTS UNDERWENT A FIVE-YEAR STUDY IN WHICH FLOSEAL WAS USED WITH LAPAROSCOPIC OVARIAN CYSTECTOMY OF OVARIAN ENDOMETRIOMAS. TWO PATIENTS EXPERIENCED UNSPECIFIED POST-OPERATIVE INFECTIONS. THE CAUSE OF THE INFECTIONS WAS NOT REPORTED. TREATMENT FOR THE EVENTS WAS NOT REPORTED. THE STUDY REPORTED THE PATIENTS WERE DISCHARGED FROM THE HOSPITAL (NO FURTHER DETAILS). AT THE TIME OF THIS REPORT, THE PATIENT OUTCOMES WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366461 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other