MAUDE Adverse Event Report: JOHNSON & JOHNSON / RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD. KY WARMING JELLY TURN UP THE HEAT; LUBRICANT, PERSONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Rash (2033); Burning Sensation (2146); Dysuria (2684); Blister (4537); Swelling/ Edema (4577)

Event Date 07/21/2021

Event Type  Injury  

Event Description

Vaginal swelling; after using ky warming jelly, there was an ongoing burning sensation that led to swelling, rash, blisters, painful urination, and fever.

• Brand Name: KY WARMING JELLY TURN UP THE HEAT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): JOHNSON & JOHNSON / RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD.
• MDR Report Key: 12245242
• MDR Text Key: 264273452
• Report Number: MW5102828
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Other
• Patient Age: 36 YR
• Patient Weight: 81