BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAFILM

    MDR report key: 16665526 · Received April 3, 2023

    Report

    Report Number
    1416980-2023-01483
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    December 5, 2022
    Report Date
    April 3, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MCN
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY IN WHICH SEPRAFILM WAS USED. SEPRAFILM WAS APPLIED TO PELVIC FLOOR AND UTERINE STUMP SUTURES. SEVEN DAYS POST-OPERATIVE THE PATIENT WAS DISCHARGED HOME. FOUR DAYS AFTER DISCHARGE, THE PATIENT EXPERIENCED A FEVER (38°C). THREE DAYS LATER, THE PATIENT PRESENTED TO THE HOSPITAL FOR AN ECHO EXAM AND A DIAGNOSIS OF PELVIC FLOOR ABSCESS WAS MADE. THE FOLLOWING DAY, THE PATIENT WAS HOSPITALIZED AND TREATED WITH CHLORAMPHENICOL (TABLET 100MG X 1/1 DAY), (MIYA BM 1G X 3 TIMES/DAY) AND TAZOPIPE (4.5 G X 3/1DAY). VAGINAL CLEANSING WAS STARTED AND ADMINISTRATED UNTIL DISCHARGE (FOUR DAYS AFTER ADMISSION). AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529328 SEPRAFILM BARRIER, ABSORABLE, ADHESION MCN BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Hospitalization| R