BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUTRIFILL

    MDR report key: 22318874 · Received June 24, 2025

    Report

    Report Number
    3016114779-2025-00041
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    December 4, 2024
    Report Date
    June 24, 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 EYE PAIN AND BURNING/STINGING IN RIGHT EYE, ESPECIALLY WHEN BLINKING. THE PAIN SUBSIDED WHILST WEARING LENSES DURING THE DAY BUT LATER GOT WORSE. (B)(6) INDICATED THAT THEY VISITED THEIR DOCTOR THE FOLLOWING DAY AND WAS DIAGNOSED WITH A CORNEAL ULCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654226 NUTRIFILL NUTRIFILL MRC ASEPT PAK HFH OR HKK 00850012123002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention