MAUDE Adverse Event Report: RECKITT BENCKISER KY JELLY PERSONAL LUBRICANT

Lot Number 619752

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Rash (2033); Burning Sensation (2146); Discomfort (2330); Reaction (2414)

Event Date 10/23/2016

Event Type  Injury  

Event Description

Burning rash and pain in genitals where product was used.Symptoms are worse when continued use.I have used the same brand product lubricant (b)(4) liquid for years with no problems until i used this slightly different product (b)(4).Now i am having a rash that is continually burning if i keep using it.Rash discomfort allergic reaction.How was it taken or used: vaginal.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.Sex intimacy.

• Brand Name: KY JELLY PERSONAL LUBRICANT
• Type of Device: KY JELLY PERSONAL LUBRICANT
• Manufacturer (Section D): RECKITT BENCKISER
• MDR Report Key: 6060242
• MDR Text Key: 58651166
• Report Number: MW5065644
• Device Sequence Number: 1
• Product Code: NUC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/31/2018
• Device Lot Number: 619752
• Other Device ID Number: 619752
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 65