MAUDE Adverse Event Report: RECKITT BENCKISER LLC KY LIQUID PERSONAL LUBRICANT

Device Problems Device Ingredient or Reagent Problem (2910); Packaging Problem (3007)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 08/30/2017

Event Type  Injury  

Event Description

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.".

• Brand Name: KY LIQUID PERSONAL LUBRICANT
• Type of Device: KY LIQUID PERSONAL LUBRICANT
• Manufacturer (Section D): RECKITT BENCKISER LLC
• MDR Report Key: 7203006
• MDR Text Key: 97749776
• Report Number: MW5074659
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 61