BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELOX GAUZE

    MDR report key: 15587795 · Received October 12, 2022

    Report

    Report Number
    3003188818-2022-00003
    Event Type
    Injury
    Date Received
    October 12, 2022
    Date of Event
    July 16, 2022
    Report Date
    February 16, 2023
    Manufacturer
    MEDTRADE PRODUCTS LIMITED
    Product Code
    FRO
    PMA / PMN Number
    K080097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CELOX GAUZE IS CLEARED AS A TEMPORARY EXTERNAL USE DEVICE. THE CAUSE OF THE INFECTION IS UNKNOWN AT THIS STAGE AND FURTHER INFORMATION HAS BEEN REQUESTED FROM THE HOSPITAL IN GERMANY. NOTE: THIS MODEL IS NOT SOLD INTO THE USA BUT IS THE SAME COMPOSITION AS A PRODUCT THAT IS SOLD INTO THE USA UNDER K080097.

    Additional Manufacturer Narrative · 0

    IN CONCLUSION, A REVIEW OF DATA PROVIDED BY DR. RAMSAUER BY MEDTRADE TECHNICAL, MICROBIOLOGY AND CLINICAL EXPERTS DID NOT IDENTIFY A CAUSAL LINK BETWEEN THE STERILE CELOX TAMPONADE PRODUCT AS DELIVERED AND THE SYMPTOMS EXPERIENCED BY THE 2 PATIENTS.

    Description of Event or Problem · 0

    (B)(6) - BIRTH WITH MASSIVE POSTPARTUM BLEEDING, RE-INSERTION OF A CELOX TAMPONADE, AFTER ABOUT 24 HOURS REMOVAL OF THE TAMPONADE, AFTER 36 HOURS THE SAME SYMPTOMATOLOGY. FINDINGS CONFIRMED.

    Description of Event or Problem · 0

    (B)(6) - BIRTH WITH MASSIVE POSTPARTUM BLEEDING, RE-INSERTION OF A CELOX TAMPONADE, AFTER ABOUT 24 HOURS REMOVAL OF THE TAMPONADE, AFTER 36HOURS THE SAME SYMPTOMATOLOGY. FINDINGS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883338 CELOX GAUZE HEMOSTATIC GAUZE FRO MEDTRADE PRODUCTS LIMITED FG08834101 2145 & 222745

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other