MAUDE Adverse Event Report: BIOFILM, INC. ASTROGLIDE SPRAY 'N GLIDE PREMIUM SILICONE PERSONAL LUBRICANT SPRAY; LUBRICANT, PERSONAL

Lot Number F216706

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)

Event Date 12/20/2023

Event Type  Injury  

Event Description

I used the product according to the directions, and felt a burning and stinging sensation on and around my genitals.It lasted for a few minutes, then went away.I'm upset because the ingredients label doesn't list the propellant, so i don't know what might have caused this reaction.

• Brand Name: ASTROGLIDE SPRAY 'N GLIDE PREMIUM SILICONE PERSONAL LUBRICANT SPRAY
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): BIOFILM, INC.
• MDR Report Key: 18394388
• MDR Text Key: 331397449
• Report Number: MW5149551
• 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: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: F216706
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ACYCLOVIR; ANTACID; CALCIUM SUPPLEMENT ; DESVENLAFAXINE ; FLEXERIL ; GABAPENTIN ; HYDROCHLOROTHIAZIDE ; OMEPRAZOLE ; VITAMIN D ; VYVANSE
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White