BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 22168028 · Received June 9, 2025

    Report

    Report Number
    2243441-2025-00030
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 14, 2025
    Report Date
    June 9, 2025
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE COMPLAINT AFFECTS FILTER NEEDLES CO-PACKED WITH VABYSMO. ON AN UNKNOWN DATE, THE PATIENT DEVELOPED ENDOPHTHALMITIS WHILST BEING TREATED WITH VABYSMO PFS (6MG/0.05ML). THE EVENT OCCURRED POST-TREATMENT. THERE WAS NO PATIENT INJURY AND/OR REQUIRE MEDICAL OR SURGICAL INTERVENTION. THE PROCEDURE OUTCOME AND PATIENT IMPACT WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477979 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V NF-3013RBKE05M 2410003

    Patients

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