BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 25115903 · Received May 7, 2026

    Report

    Report Number
    2243441-2026-00021
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    September 17, 2025
    Report Date
    May 7, 2026
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    UDI-DI
    05413206251223
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    TERUMO RECEIVED THE FOLLOWING INFORMATION: HEALTHCARE PROFESSIONAL REPORTED BILATERAL STERILE ENDOPHTHALMITIS AND VASCULITIS AFTER VABYSMO, PFS 6MG, (LOTB7005B09, EXP DATE: 30APR2026) INTRAVITREAL INJECTION ON (B)(6) 2025. PATIENT HAD BEEN RECEIVING THIS DRUG WITHOUT INCIDENT FOR ABOUT NINE MONTHS. IN THE WEEKS FOLLOWING (B)(6) 2025, SHE REPORTED DECLINE IN VISION OU WITH FLOATERS. WHEN SHE PRESENTED ON (B)(6) 2025, SHE HAD BILATERAL DENSE ENDOPHTHALMITIS. VITRECTOMY WITH VITREOUS BIOPSY WAS PERFORMED ON ONE EYE WITH INJECTION OF BROAD-SPECTRUM ANTIBIOTICS. INTRAOPERATIVE VIEW SHOWED VASCULITIS. DECLINE IN VISION IN BOTH EYES (OU) WITH FLOATERS, BILATERAL DENSE ENDOPHTHALMITIS. VITRECTOMY WITH VITREOUS BIOPSY WAS PERFORMED ON ONE EYE WITH INJECTION OF BROAD-SPECTRUM ANTIBIOTICS. INTRAOPERATIVE VIEW SHOWED VASCULITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624333 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2407010 05413206251223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SYRINGE (FOR PRODUCT VABYSMO)