BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERUMO INJECTION FILTER NEEDLE

    MDR report key: 22023062 · Received May 14, 2025

    Report

    Report Number
    2243441-2025-00024
    Event Type
    Injury
    Date Received
    May 14, 2025
    Date of Event
    February 4, 2025
    Report Date
    May 14, 2025
    Manufacturer
    TERUMO EUROPE N.V
    Product Code
    QYM
    UDI-DI
    05413206251223
    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, SUSPECTED TO BE DUE TO THE TRANSMISSION OF AN INFECTIOUS AGENT VIA THE MEDICINAL PRODUCT. THE REPORTER ASSESSED THE SUSPECTED TRANSMISSION OF THE INFECTIOUS AGENT AS RELATED TO VABYSMO. THE COMPANY ALSO ASSESSED THE CAUSALITY OF ENDOPHTHALMITIS AS RELATED TO VABYSMO. THE EVENT OCCURRED POST-TREATMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748222 TERUMO INJECTION FILTER NEEDLE OPHTHALMIC NEEDLE QYM TERUMO EUROPE N.V N/A 2408009 05413206251223

    Patients

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