BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELOX GAUZE

    MDR report key: 16372059 · Received February 14, 2023

    Report

    Report Number
    3003188818-2023-00001
    Event Type
    Injury
    Date Received
    February 14, 2023
    Date of Event
    December 23, 2022
    Report Date
    February 14, 2023
    Manufacturer
    MEDTRADE PRODUCTS LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K080097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CELOX GAUZE IS CLEARED AS A TEMPORARY EXTERNAL USE DEVICE. THE DEVICE HAS BEEN USED OFF-LABEL AND CAUSE OF THE EVENT CANNOT BE ESTABLISHED AS DEVICE RELATED. NOTE: THIS MODEL IS NOT SOLD IN THE USA BUT HAS THE SAME COMPOSITION AS A PRODUCT THAT IS SOLD INTO THE USA UNDER K080097.

    Description of Event or Problem · 0

    THE REPORT IDENTIFIED 1 PATIENT THAT WAS DIAGNOSED WITH PULMONARY VENOUS CONGESTION WITH BILATERAL SEROUS PLEURAL EFFUSION WITH PARTIAL ATELECTASIS AFTER TREATMENT OF POST-PARTUM HAEMORRHAGE USING A CELOX GAUZE PRODUCT WITH LATEST DEVELOPMENT FROM (B)(6) 2023 PERSISTENT ACUTE RENAL INSUFFICIENCY REQUIRING DIALYSIS, PLEURAL EFFUSION ON BOTH SIDES POST-PARTUM HAEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388744 CELOX GAUZE HEMOSTATIC FRO MEDTRADE PRODUCTS LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Other