BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22297683 · Received June 20, 2025

    Report

    Report Number
    3016114779-2025-00025
    Event Type
    Injury
    Date Received
    June 20, 2025
    Date of Event
    January 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    ASEPT PAK
    Product Code
    MRC
    UDI-DI
    00850012123002
    PMA / PMN Number
    K181566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT (B)(6) INDICATED THAT THEY HAD EXPERIENCED AN EXTREMELY RED AND BURNING EYE ON (B)(6) 2025. (B)(6) INDICATED THAT THEIR DOCTOR CONFIRMED AN ULCER AND PRESCRIBED MEDICATION DROPS. (B)(6) INDICATED THAT THEY SWITCHED FILLING SOLUTION AND HAVE NOT HAD ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1806957 NUTRIFILL NUTRIFILL MRC ASEPT PAK HKK 00850012123002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention