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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Itching Sensation (1943); Rash (2033); Burning Sensation (2146)

Event Date 01/25/2020

Event Type  Injury  

Event Description

Put on ky jelly and started to feel a slight burning and itching sensation.Within minutes there was a major rash/ burn that was beginning to blister.I¿ve used this exact products many times with zero side affects.It affected any skin it came in contact with in intercourse.Did the problem stop after the person rescued the dose or stopped taking or using the product? no.

• Brand Name: KY JELLY PERSONAL LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE MANUFACTURING (THAILAND) LTD.
• MDR Report Key: 9641587
• MDR Text Key: 177027417
• Report Number: MW5092573
• 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: 01/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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 Age: 30 YR
• Patient Weight: 54