MAUDE Adverse Event Report: KY BRAND MARQUE WARMING LIQUID; KY JELLY WARMING LIQUID

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2015

Event Type  Injury  

Event Description

I, along with my boyfriend, went away for a weekend.I used ky jelly warming liquid.Well, that was the beginning of one of the worst weeks in my life and also the wrecking of the weekend.First, i called and the person i had to speak with was rude, disinterested, and said there was nothing that she could do.I asked to speak with the manger in charge, she said she was that person.I contacted attorney (b)(6) to represent me and he spoke with (b)(6); ref: (b)(4).I have tried to contact (b)(6) myself but to no avail.I've subsequently texted and called attorney (b)(6) and he hasn't responded, which leaves me to assume he doesn't have any updates.All info has been forwarded via attorney to ky (as per attorney).Reason for use: dryness.Is the product over the counter: yes; event abated after use, stopped or dose reduced: no.

• Brand Name: KY BRAND MARQUE WARMING LIQUID
• Type of Device: KY JELLY WARMING LIQUID
• MDR Report Key: 5553767
• MDR Text Key: 42170770
• Report Number: MW5061520
• Device Sequence Number: 1
• Product Code: KMJ
• 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: 04/01/2016

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: 04/01/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 104