ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT

Received Feb 8, 2019 · Event occurred Feb 6, 2019

Report MW5083860 · MDR key 8321910

Device

Generic name

Lubricant, Personal

Manufacturer

Biofilm Inc.

Lot number

A011267

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

54 YR

Inflammation
Burning Sensation
Inflammation
Burning Sensation

Narrative

Description of Event or Problem

I USED THE ULTRA-GEL PERSONAL LUBRICANT FROM ASTROGLIDE. I APPLIED IT TO MY FIANCÉ AND WHEN HE WAS INSERTED, IT BURNED ME. HE FELT THE WARMING FEELING ALSO. I AM STILL INFLAMED A DAY LATER. IS THE PRODUCT OVER -THE -COUNTER? YES, HOW WAS TAKEN OR USED: TOPICAL, DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2019. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019. WHY WAS THE PERSON USING THE PRODUCT? PERSONAL DRYNESS.