FDA Adverse Event Injury Summary report: N

KY LIQUID PERSONAL LUBRICANT

MDR report key: 7203006 · Received January 17, 2018

Report

Report Number
MW5074659
Event Type
Injury
Date Received
January 17, 2018
Date of Event
August 30, 2017
Report Date
January 13, 2018
Manufacturer
RECKITT BENCKISER LLC
Product Code
NUC
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
HI, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE USED KY LIQUID PERSONAL LUBRICANT FOR MOST IF NOT ALL OF MY ADULT LIFE UP TILL NOW. IN (B)(6), I HAD A SEVERE ADVERSE REACTION. THE INGREDIENTS ARE NOT POSTED ON THE BOTTLE, SO I COULDN'T TELL WHAT MAY HAVE CAUSED IT. I'M ALLERGIC TO GLUTEN. ANYWAY, THE FIRST TIME IT HAPPENED, I THOUGHT IT MUST BE SOMETHING ELSE, AN INFECTION OR SOMETHING. I BOUGHT ANOTHER PERSONAL LUBRICANT JUST IN CASE, BUT I DIDN'T LIKE IT. THEN NEXT TIME I USED KY I HAD THE SAME REACTION. I WAS TRAVELING THIS TIME AND HAD TO VISIT A GYN AT A UNIVERSITY. SHE ACTUALLY TESTED ME FOR SEVERAL INFECTIONS, GARDNERELLA VAGINALIS, GONORRHOEAE, AND TRICHOMONAS VAGINALIS. MY REACTION WAS THAT STRONG. THE TESTS WERE NEGATIVE. I'VE TRIED TO FIND THE INGREDIENTS ONLINE TO NO AVAIL. I'VE SWITCHED TO A PERSONAL LUBRICANT THAT I BOUGHT AT A NATURAL HEALTH STORE. THERE IS A WARNING THAT SAYS IF IRRITATION OCCURS DISCONTINUE USE AND SEE A DOCTOR. THE THING IS, I THINK THAT INGREDIENTS SHOULD BE ON THE BOTTLE WITH ALLERGY INFO. JUST AS IS DONE WITH FOOD. I'M OUT THE MONEY I SPENT. WHY SHOULD THE INGREDIENTS BE A SECRET. THIS PRODUCT IS FOR INTIMATE USE. FREQUENCY: AS NEEDED. HOW WAS IT TAKEN OR USED: VAGINAL. "IS THE PRODUCT OVER-THE-COUNTER: YES." DATES OF USE: (B)(6) 2017. "DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: NO; DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: YES."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
42172 KY LIQUID PERSONAL LUBRICANT KY LIQUID PERSONAL LUBRICANT NUC RECKITT BENCKISER LLC

Patients

Seq Age Sex Outcome Treatment
1 69 YR Disability