BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIX ULTRA LICE TREATMENT KIT

    MDR report key: 7922471 · Received October 1, 2018

    Report

    Report Number
    3011801804-2018-00002
    Event Type
    Injury
    Date Received
    October 1, 2018
    Date of Event
    July 15, 2018
    Report Date
    August 13, 2018
    Manufacturer
    PRESTIGE BRANDS INC.
    Product Code
    LJL
    PMA / PMN Number
    K163401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS SERIOUS CASE REPORTED TO COMPANY REFERS TO A (B)(6) FEMALE WITH A MEDICAL HISTORY OF HIGH BLOOD PRESSURE, TREATED WITH METOPROLOL 25MG ONCE PER DAY. ON (B)(6) 2018, A CONSUMER USED NIX ULTRA LIQUID TO TREAT HEAD LICE AND EXPERIENCED HEADACHE, NAUSEA AND INCREASE IN BLOOD PRESSURE. CONSUMER APPLIED PRODUCT TO HAIR OVER A SINK AND THE PRODUCT ACCIDENTALLY "WENT UP HER NOSE": SHE INSTANTLY GOT A "POUNDING" HEADACHE AND WAS TAKEN FOR MEDICAL EVALUATION. BLOOD PRESSURE WAS REPORTED TO BE ELEVATED UPON ARRIVAL TO CLINIC. EXACT BP NOT KNOWN. CONSUMER WAS TREATED WITH CLONIDINE 0.1MG X2 WITH NO EFFECT ON LOWERING HER BP. CONSUMER WAS THEN TAKEN TO THE EMERGENCY DEPARTMENT BY HER SON AND UPON ARRIVAL HER BP 205/94. SHE WAS TREATED WITH "IV BENADRYL AND PROMETHAZINE" THEN RELEASED HOME. ON (B)(6) 2018, CONSUMER RETURNED TO EMERGENCY DEPARTMENT WITH "POUNDING HEADACHE, HIGH BP AND NAUSEA". CT OF THE HEAD WAS NEGATIVE. BP 199/99. CONSUMER WAS TREATED WITH "SODIUM CHLORIDE, DIPHENHYDRAMINE 50MG, DEXAMETHASONE 10MG, KETOROLAC 30MG, AND METOCLOPRAMIDE 5MG". IT WAS REPORTED THAT BP STABILIZED AT 156/77, HEADACHE SUBSIDED AND CONSUMER RELEASED HOME WITH AN INCREASED STRENGTH OF METOPROLOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765308 NIX ULTRA LICE TREATMENT KIT LICE REMOVAL KIT LJL PRESTIGE BRANDS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| O