K-Y WARMING ULTRAGEL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-04 for K-Y WARMING ULTRAGEL manufactured by Kik Customs Products.

Event Text Entries

[552356] Consumer reported: after use of product, consumer suffered from a miscarriage. Consumer is unsure if it is product related. "i utilized your product during pregnancy because of the extreme dryness, and also to assist with intercourse in the case of dryness. I utilized the product frequently with satisfaction. To make a long story short, i lost my baby and doctors could not find one reason why a perfect pregnancy turned. I was questioned over and over about if there was any products or meds used that the dr or hosp staff was unaware of that could have possibly caused the unfortunate situation, i was too embarrassed to mention to them or my husband that i had to use the product. But, in the back of my mind -- only because the product label mentions no side effects have been recorded or studies on the effects of use while pregnant, i wonder if this could have been a possible side effect. I mean if no one ever mentions it, how could it? I just want to know so that next time a different product will be used or so others don't have to go through what i did, if the product is a possible danger to a fetus, or can cause what it did in my situation. Please check into it to see - don't let others go through this. I am not upset, just want others to be warned if the product is a potential hazard. No additional info available at this time.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2214133-2007-00001
• MDR Report Key: 804736
• Date Received: 2007-01-04
• Date of Event: 2006-12-01
• Date Added to Maude: 2007-01-17
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: K-Y WARMING ULTRAGEL
• Generic Name: PERSONAL LUBRICANT
• Product Code: MMS
• Date Received: 2007-01-04
• Model Number: NA
• Catalog Number: NA
• Lot Number: 0054C
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 792234
• Manufacturer: KIK CUSTOMS PRODUCTS
• Manufacturer Address: 13 BETHRIDGE RD. ETOBICOKE, ONTARIO CA M9W1M6

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2007-01-04