MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD KY WARMING LIQUID; LUBRICANT, PERSONAL

Lot Number AAZ0278

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Blister (4537)

Event Date 07/12/2023

Event Type  Injury  

Event Description

A few days after using ky sensational personal lubricant, i began itching in my inner thigh (bikini line).One or 2 more days passed and i began to notice blister like spots in the same place, now hurting to the point i'm unable to wear underwear.Unsure as to what i should put on these spots other than clean them well and use neosporin.I'd just like to warn others so it doesn't happen to anyone else.

• Brand Name: KY WARMING LIQUID
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD
• MDR Report Key: 17390843
• MDR Text Key: 319844224
• Report Number: MW5120014
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: AAZ0278
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White