KY LIQUID PERSONAL LUBRICANT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for KY LIQUID PERSONAL LUBRICANT manufactured by Reckitt Benckiser Llc.

Event Text Entries

[97749776] 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. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5074659
MDR Report Key7203006
Date Received2018-01-17
Date of Report2018-01-13
Date of Event2017-08-30
Date Added to Maude2018-01-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameKY LIQUID PERSONAL LUBRICANT
Generic NameKY LIQUID PERSONAL LUBRICANT
Product CodeNUC
Date Received2018-01-17
Device Expiration Date2018-07-31
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerRECKITT BENCKISER LLC


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2018-01-17

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