BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELOX GAUZE

    MDR report key: 22174538 · Received June 10, 2025

    Report

    Report Number
    3003188818-2025-00003
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    March 27, 2025
    Report Date
    April 22, 2025
    Manufacturer
    MEDTRADE PRODUCTS LIMITED
    Product Code
    QSY
    PMA / PMN Number
    K080097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INCIDENT WAS DESCRIBED AS: DUE TO AN UNCONTROLLABLE UTERINE BLEEDING DURING THE REMOVAL OF THE PLACENTAL REMNANTS, THE CAVUM UTERI WAS TAMPONADE WITH THE CELOX TAMPONADE. THIS PRIMARILY LED TO GOOD HEMOSTASIS. ON THE SAME EVENING, THE PATIENT DEVELOPED PRONOUNCED CONJUNCTIVITIS, WHICH WAS THEN TREATED PROFESSIONALLY. THE TAMPONADE WAS REMOVED THE NEXT MORNING WITHOUT COMPLICATIONS. IN THE FURTHER COURSE OF THE DISEASE, DESPITE THE APPROPRIATE THERAPY, THE SYMPTOMS WORSENED, IRIDOCYCLITIS WITH REDUCED VISION AND AT THE SAME TIME THE PATIENT SUFFERED (TEMPORARY) HEARING DAMAGE. AS A RESULT, THE PATIENT WAS TRANSFERRED TO THE (B)(6) HOSPITAL IN (B)(6). THE COLLEAGUES FROM (B)(6) SUSPECT AN ALLERGIC REACTION TO THE CELOX TAMPONADE. CELOX GAUZE IS CLEARED AS A TEMPORARY EXTERNAL USE DEVICE TO CONTROL BLEEDING. WHILST THERE IS NO DEFINITIVE EVIDENCE OF A CAUSAL LINK TO THE TRANSIENT VISION OR AUDITORY IMPAIRMENT WITH CELOX AND THE THIS SPECIFIC MODEL DEVICE HAS BEEN USED OFF-LABEL, THE CAUSE OF THE EVENT CANNOT BE ESTABLISHED AS DEVICE RELATED AT THIS TIME. NOTE: THIS MODEL IS NOT SOLD IN THE USA BUT HAS THE SAME COMPOSITION AS A PRODUCT THAT IS SOLD INTO THE USA UNDER 510(K) K080097.

    Description of Event or Problem · 0

    DUE TO AN UNCONTROLLABLE UTERINE BLEEDING DURING THE REMOVAL OF THE PLACENTAL REMNANTS, THE CAVUM UTERI WAS TAMPONADE WITH THE CELOX TAMPONADE. THIS PRIMARILY LED TO GOOD HEMOSTASIS. ON THE SAME EVENING, THE PATIENT DEVELOPED PRONOUNCED CONJUNCTIVITIS, WHICH WAS THEN TREATED PROFESSIONALLY. THE TAMPONADE WAS REMOVED THE NEXT MORNING WITHOUT COMPLICATIONS. IN THE FURTHER COURSE OF THE DISEASE, DESPITE THE APPROPRIATE THERAPY, THE SYMPTOMS WORSENED, IRIDOCYCLITIS WITH REDUCED VISION AND AT THE SAME TIME THE PATIENT SUFFERED (TEMPORARY) HEARING DAMAGE. AS A RESULT, THE PATIENT WAS TRANSFERRED TO THE (B)(6) HOSPITAL IN (B)(6). THE COLLEAGUES FROM (B)(6) SUSPECT AN ALLERGIC REACTION TO THE CELOX TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265925 CELOX GAUZE HEMOSTATIC GAUZE QSY MEDTRADE PRODUCTS LIMITED FG088308031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other