BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLUMAT MC AGILIA BR

    MDR report key: 25340418 · Received May 29, 2026

    Report

    Report Number
    3000240707-2026-00215
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 22, 2026
    Report Date
    May 29, 2026
    Manufacturer
    FRESENIUS VIAL S.A.S
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    THE FOLLOWING HAS BEEN REPORTED: PATIENT PRESENTED NAUSEA, HYPERSENSITIVITY REACTION, AND BLURRED VISION DURING THE INFUSION. AFTER THE ONSET OF THE ADVERSE REACTION, THE INFUSION WAS TEMPORARILY INTERRUPTED AND SUBSEQUENTLY RESUMED. THERE WERE ADDITIONAL PAUSES DURING THE INFUSION FOR BATHROOM BREAKS. MEDICATION: PACLITAXEL 160.8 MG START OF MEDICATION USE: (B)(6) 2026 13:10. INFUSION INTERRUPTION AFTER THE ONSET OF THE ADR: (B)(6) 2026 13:16. INFUSION RESUMED: (B)(6) 2026 14:15. END OF INFUSION: (B)(6) 2026 16:00 (BATHROOM BREAKS). REPORTING AS A CONSERVATIVE MEASURE. ADVERSE EVENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391342 VOLUMAT MC AGILIA BR INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S Z019140

    Patients

    Seq Age Sex Outcome Treatment
    1