BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIX ULTRA SHAMPOO

    MDR report key: 20070547 · Received August 26, 2024

    Report

    Report Number
    1719513-2024-00064
    Event Type
    Injury
    Date Received
    August 26, 2024
    Product Code
    LJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INITIAL (16-AUG-2024): THIS SERIOUS CASE REPORTED BY RETAILER-WHOLESALER VIA EMAIL REFERS TO A 6 YEAR-OLD FEMALE WHOSE MEDICAL HISTORY, CONCOMITANT MEDICATIONS AND ALLERGIES WERE NOT REPORTED. THE MOTHER CALLED AND REPORTED THAT SHE USED NIX ULTRA SHAMPOO ON HER DAUGHTER AND DURING APPLICATION THE PRODUCT GOT INTO HER DAUGHTER'S EYE AND CAUSED BURNING. THE INDICATION FOR USE WAS NOT PROVIDED. THEY WENT TO AN URGENT CARE AND THEN TO THE EMERGENCY ROOM WHERE THEY STAYED OVER NIGHT. SHE WAS GIVEN 4 DIFFERENT UNKNOWN EYEDROPS TO BE ADMINISTERED EVERY 4 HOURS. THIS CASE OUTCOME IS UNKNOWN. MEDDRA VERSION 27.0 EXPECTEDNESS: EYE IRRITATION: EXPECTED ACCIDENTAL EXPOSURE TO PRODUCT ACCORDING TO THE COMPANY REFERENCE SAFETY INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953897 NIX ULTRA SHAMPOO DETECTORS AND REMOVERS, LICE, (INCLUDING COMBS) LJL

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female Hospitalization| O| R