MAUDE Adverse Event Report: JOHNSON & JOHNSON PROFESSIONALS, INC./ MEIYUME MANUFACTURING (THAILAND) LIMITED KY JELLY EST1904 WATER BASED PERSONAL LUBRICANT FOR WETTER SEX GLIDE; LUBRICANT, PERSONAL

Model Number NDC NUMBER: 3168617

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Fluid Discharge (2686)

Event Date 10/29/2022

Event Type  Injury  

Event Description

Since using the product my vagina only spewing out a watery substance.(b)(4), mild i think g grams.Takes at bedtime, taken by vaginal.

• Brand Name: KY JELLY EST1904 WATER BASED PERSONAL LUBRICANT FOR WETTER SEX GLIDE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): JOHNSON & JOHNSON PROFESSIONALS, INC./ MEIYUME MANUFACTURING (THAILAND) LIMITED
• MDR Report Key: 15732401
• MDR Text Key: 303171935
• Report Number: MW5113063
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• Reporter Country Code: TD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/18/2024
• Device Model Number: NDC NUMBER: 3168617
• Device Lot Number: 437II1
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: AMLOPRES
• Patient Outcome(s): Required Intervention
• Patient Age: 46 DA
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American