BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRIFILL

    MDR report key: 22053438 · Received May 20, 2025

    Report

    Report Number
    MW5170611
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 9, 2025
    Report Date
    May 15, 2025
    Manufacturer
    CONTAMAC SOLUTIONS, INC.
    Product Code
    MRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REDNESS OF EYES CONTINUED AND A COUPLE DAYS LATER A RECALL EMAIL WAS SENT TO MY EMAIL STATING THAT CORNEAL ULCERS COULD OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78433 NUTRIFILL PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE MRC CONTAMAC SOLUTIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female PARA IRENE 40MG.