BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOT APPLICABLE

    MDR report key: 23937410 · Received December 31, 2025

    Report

    Report Number
    1911916-2025-00818
    Event Type
    Injury
    Date Received
    December 31, 2025
    Date of Event
    February 13, 2025
    Report Date
    January 19, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052004
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (B) DATE OF EVENT HAS SINCE BEEN CLARIFIED. INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 07-JAN-2026: ¿ON (B)(6) 2025 AT 7:19 AM DROP WAS DILUTED USING BRITM TECHNIQUE WITH PROPARACAINE 0.5% DROPS, TROPICAMIDE 1% AND PHENYLEPHRINE 2.5% IN OS.¿ "PRESCRIPTION WAS SENT TO PHARMACY FOR DUREZOL 0.5MG EVERY HOUR ALTERNATES WITH OLFLOXACIN 0.3MG EVERY HOUR.¿

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED BY CUSTOMER ON 07-JAN-2026: WHAT MEDICAL INTERVENTION WAS PROVIDED TO PATIENT? ¿ON (B)(6) 2025 AT 7:19 AM DROP WAS DILUTED USING BRITM TECHNIQUE WITH PROPARACAINE 0.5% DROPS, TROPICAMIDE 1% AND PHENYLEPHRINE 2.5% IN OS.¿ "PRESCRIPTION WAS SENT TO PHARMACY FOR DUREZOL 0.5MG EVERY HOUR ALTERNATES WITH OLFLOXACIN 0.3MG EVERY HOUR.¿

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305200. BATCH # 2172517. VERBATIM: ADVERSE EVENT - ENDOPHTHALMITIS PATIENT EXPERIENCED AN ADVERSE EVENT POST INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2549107 NOT APPLICABLE NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 2172517 00382903052004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other