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

Lot Number "A016310?"

Patient Problems Erythema (1840); Superficial (First Degree) Burn (2685)

Event Date 10/15/2023

Event Type  Injury  

Event Description

Used the astroglide as a personal lubricant and ended up with red surface burned skin with some spots down an extra layer or two of skin compared to other spots.Some burning internally.

• Brand Name: ASTROGLIDE
• Type of Device: LUBRICANT, PERSONAL
• Manufacturer (Section D): BIOFILM, INC.
• MDR Report Key: 18059379
• MDR Text Key: 327390450
• Report Number: MW5147661
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: "A016310?"
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CHLOROTHIADONE; ELIQUIS; LISINOPRIL; METOPRALOL; MULTIVITAMIN ; OMEPRAZOLE; VIT D; ZINC
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White