BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIX ULTRA LICE REMOVAL KIT

    MDR report key: 21035123 · Received December 30, 2024

    Report

    Report Number
    1719513-2024-00084
    Event Type
    Injury
    Date Received
    December 30, 2024
    Product Code
    LJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INITIAL (14-DEC-2024): THIS SERIOUS CASE REPORTED VIA EMAIL REFERS TO A FEMALE CONSUMER WHOSE AGE, MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. THE CONSUMER USED THE NIX ULTRA LICE TREATMENT KIT FOR LICE PREVENTION AND EXPERIENCED AN EYE BURN, EYE SWELLING, AND EYE STINGING. SHE WENT TO THE OPHTHALMOLOGIST AND A LENS WAS PUT IN THE EYE AND SHE WAS PRESCRIBED PREDNISONE EYE DROPS AND ANTIBIOTICS. SHE ADVISED THAT SHE LIKELY GOT SOME IN HER EYE DURING USE. THIS CASE OUTCOME IS RECOVERING/RESOLVING. MEDDRA VERSION 27.1. EXPECTEDNESS: CHEMICAL BURN OF EYE: UNEXPECTED, EYE PAIN: UNEXPECTED, EYE SWELLING: UNEXPECTED, ACCIDENTAL EXPOSURE TO PRODUCT, DEVICE USE ISSUE. ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814091 NIX ULTRA LICE REMOVAL KIT DETECTORS AND REMOVERS, LICE, (INCLUDING COMBS) LJL 2024G18

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R