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

Lot Number A011267

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

Patient Problems Inflammation (1932); Burning Sensation (2146)

Event Date 02/06/2019

Event Type  No Answer Provided  

Event Description

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.

• Brand Name: ASTROGLIDE ULTRA GENTLE GEL PERSONAL LUBRICANT
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): BIOFILM INC.; vista CA
• MDR Report Key: 8321910
• MDR Text Key: 135572432
• Report Number: MW5083860
• Device Sequence Number: 1
• Product Code: NUC
• Combination Product (y/n): N
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Device Operator: No Information
• Device Expiration Date: 08/29/2021
• Device Lot Number: A011267
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 101