MAUDE Adverse Event Report: K-Y WARMING SENSATION

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

Patient Problems Burning Sensation (2146); Patient Problem/Medical Problem (2688)

Event Date 04/28/2016

Event Type  Injury  

Event Description

I used ky warming lube and had this really bad burning occur.A few days after i used it i noticed i couldn't walk and i had bumps inside and around my vulva, like how they would describe herpes to be.

• Brand Name: K-Y WARMING SENSATION
• Type of Device: K-Y WARMING SENSATION
• MDR Report Key: 5633767
• MDR Text Key: 44562945
• Report Number: MW5062098
• Device Sequence Number: 1
• Product Code: KMJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other