MAUDE Adverse Event Report: BIOFILM, INC. ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT; LUBRICANT, VAGINAL, PATIENT

Model Number	A011864
Health Effect - Clinical Codes	Burning Sensation (2146); Burn, Thermal (2530)
Date of Event	07/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
I have recently bought astroglide ultra gentle gel personal lubricant at (b)(6) in (b)(6) earlier that week.I have used the astroglide brand in the past and have been satisfied with the product.Upon external vaginal application of this one, i felt a burning sensation that jolted me and brought me to tears.I tried wiping it off but soon ran to shower to rinse it off.After the shower, i did a quick (b)(6) search of the product and noted similar reviews on the astroglide website.All of the negative reviews seemed to report the same painful burning.I assume it was a bad batch as it is only the most recent reviews, from the past month or so, are negative and the rest are fine.The next morning after vaginal sex with my partner, he noted that he also had a slight burning sensation on the base of his penis.I also had a slight burning sensation within my vaginal canal.I guess the product was so absorbant that it remained on the skin overnight, even after washing.Please investigate and remove this product from store shelves as soon as possible.Fda safety report id# (b)(4).

• Brand Name: ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT
• Common Device Name: LUBRICANT, VAGINAL, PATIENT
• Manufacturer (Section D): BIOFILM, INC.
• MDR Report Key: 8847061
• Report Number: MW5088567
• Device Sequence Number: 14071168
• Product Code: MMS
• UDI-Device Identifier: 00015594011035
• UDI-Public: 015594011035
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 07/29/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: A011864
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HAS IUD
• Patient Age: 29 YR
• Patient Weight: 50