BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTYLES EXCITE

    MDR report key: 4408326 · Received December 28, 2014

    Report

    Report Number
    MW5040153
    Event Type
    Injury
    Date Received
    December 28, 2014
    Date of Event
    December 25, 2014
    Report Date
    December 28, 2014
    Manufacturer
    ANSELL HEALTHCARE PRODUCTS, INC
    Product Code
    NUC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED LIFESTYLES EXCITE FEMALE SEXUAL STIMULATING GEL FOR THE FIRST TIME. THE DIRECTIONS WERE FOLLOWED USING JUST A "TINY" AMOUNT AND APPLIED DIRECTLY TO THE CLITORIS. THERE WAS AN IMMEDIATE BURNING AND EVEN AFTER WASHING THE AREA THOROUGHLY, THERE IS STILL ITCHING AND DISCOMFORT 3 DAYS AFTER USE. DIAGNOSIS OR REASON FOR USE: PERSONAL LUBRICANT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853193 LIFESTYLES EXCITE LUBRICANT NUC ANSELL HEALTHCARE PRODUCTS, INC 14106515HC

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR