BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUFLEXXA

    MDR report key: 24860362 · Received April 13, 2026

    Report

    Report Number
    3000164186-2026-00013
    Event Type
    Injury
    Date Received
    April 13, 2026
    Report Date
    April 13, 2026
    Manufacturer
    FERRING PHARMACEUTICALS A/S
    Product Code
    MOZ
    PMA / PMN Number
    PMA P010029¿
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS DEFAULT TEXT CONFIGURED FOR BLOCK H10.

    Description of Event or Problem · 0

    SEPTIC ARTHRITIS [ARTHRITIS BACTERIAL]. CASE NARRATIVE: THIS IS A SERIOUS SPONTANEOUS AND COMPLAINT CASE RECEIVED FROM A HEALTH PROFESSIONAL IN AUSTRALIA. THIS CASE CONCERNS A 58-YEAR-OLD MALE WHO EXPERIENCED: ON AN UNKNOWN DATE: SEPTIC ARTHRITIS, (ARTHRITIS BACTERIAL), SERIOUS (HOSPITALIZED), REPORTER CAUSALITY: RELATED, COMPANY CAUSALITY: RELATED. THE PATIENT WAS ADMINISTERED SUSPECTED PRODUCT: EUFLEXXA (SODIUM HYALURONATE) SOLUTION FOR INJECTION 1%. FURTHER PRODUCT POSOLOGY WAS NOT REPORTED. REPORTED NARRATIVE: MALE 58-YEAR-OLD SEPTIC ARTHRITIS HOSPITALISED. NO CONCOMITANT MEDICATION WAS REPORTED. ACTION TAKEN TO EUFLEXXA WAS UNKNOWN. AT THE TIME OF REPORTING, OUTCOME OF ARTHRITIS BACTERIAL: UNKNOWN. COMPLAINT INVESTIGATIONS: TREND ANALYSIS: FIVE (5) ADDITIONAL COMPLAINTS REGARDING POTENTIAL PATIENT INFECTION WERE RECEIVED SINCE APRIL 2025 AS DETAILED IN REOCCURRENCE 1 FIELD. COMPARED TO THREE (3) DURING 2024 AND ONE (1) DURING 2023. A TREND CAN BE ESTABLISHED. 2023: QR# (B)(4), EUFLEXXA 3 X 2ML: INFECTION AT INJECTION SITE / LOT: UNKNOWN (EUFLEXXA LOT UNKNOWN) FROM USA. NOT CONFIRMED. 2024: QR#(B)(4), EUFLEXXA 3 X 2ML: INFECTION / LOT: V16304A (EUFLEXXA LOT V16304A) FROM USA. QR#(B)(4), EUFLEXXA 3 X 2ML: INFECTION / LOT: V13436C (EUFLEXXA LOT V13436C) FROM USA.QR#(B)(4), SUSPECTED EUFLEXXA SAFETY CASE: INFLAMMATORY REACTION (EUFLEXXA LOT UNKNOWN) FROM ROMANIA. NONE WERE CONFIRMED. 2025: QR#(B)(4), IL- ARTHREASE - PV CASE - FER-IL-2025-042 INJECTION SITE VESICLES/BLISTERS X14507G (ARTHREASE LOT X14507G) FROM ISRAEL. NOT CONFIRMED. 2026: QR#(B)(4)- AU - EUFLEXXA - SEPTIC ARTHRITIS - Y10159E AND Y14860A QR#(B)(4) - AU1835_EUFLEXXA_SEPTIC ARTHRITIS Y14860A QR#(B)(4). EUFLEXXA - SEPTIC ARTHRITIS CASE - LOT UNKNOWN QR#(B)(4)- AU1849 - EUFLEXXA SEPTIC ARTHRITIS - LOT UNKNOWN INVESTIGATION IS ON-GOING. PENDING STERILTY TESTING RESULTS. STABILITY DATA: NO DEVIATIONS WERE REPORTED FOR EUFLEXXA ROW LOTS THAT WERE PLACED IN STABILITY DURING 2022-2025. LATEST TIME POINTS OF THE STUDIES THAT WERE REVIEWED: 1.LOT Y14860C - 6 MONTHS' TIME POINT (2025). 2.LOT Y10159E - 6 MONTHS' TIME POINT (2025). 3.LOT Y10158C - 6 MONTHS' TIME POINT (2025). 4.LOT Y10157E - 6 MONTHS' TIME POINT (2025). 5.LOT X14680C - 18 MONTHS' TIME POINT (2024). 6.LOT V19709CA - 24 MONTHS' TIME POINT (2023). 7.LOT U13904K - 36 MONTHS' TIME POINT (2022). CONCLUSION: LOT SPECIFIC INVESTIGATION COULD NOT BE PERFORMED SINCE NO INFORMATION REGARDING LOT NUMBER COULD BE RETRIEVED FROM THE COMPLAINANT.THE REVIEW OF SUPPORTING DATA DID NOT REVEAL ANY QUALITY ISSUE. THE ROOT CAUSE FOR THIS COMPLAINT CANNOT BE DETERMINED, THIS EVENT MAY BE RELATED TO USE ERROR DURING ADMINISTRATION. BTG PERFORMS A ROUTINE TREND ANALYSIS OF ALL COMPLAINT TYPES. IN CASE OF TREND INCREASE DETECTION, AN APPROPRIATE CAPA WILL BE INITIATED. CASE LISTEDNESS IS UNLISTED. SENDER COMMENT: ALTHOUGH IMPORTANT INFORMATION (SUCH AS MEDICAL HISTORY, CONCOMITANT MEDICATION) WAS NOT PROVIDED, THE CONTRIBUTION OF SODIUM HYALURONATE TO PATIENT EXPERIENCED S. AUREUS SEPTIC ARTHRITIS COULD NOT BE EXCLUDED DUE TO KNOWN SAFETY PROFILE OF HYALURONAN PREPARATIONS. THE CONSERVATIVE ASSESSMENT OF THE CAUSALITY WAS BASED ON THE INFORMATION PROVIDED IN THE REPORT. REFERENCE IDS: INTERNAL # - AFFILIATE = (B)(4). INTERNAL # - COMPLAINT = (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104310 EUFLEXXA 1%  SODIUM HYALURONATE MOZ FERRING PHARMACEUTICALS A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H| O