MAUDE Adverse Event Report: BIOFILM ASTROGLIDE PERSONAL LUBRICANT

Lot Number A003304

Device Problem Insufficient Information (3190)

Patient Problem Irritation (1941)

Event Date 02/01/2012

Event Type  Injury  

Event Description

Caused vaginal irritation.Used (b)(6) 2012 for a few days.Will not use again.Still have product used.

• Brand Name: ASTROGLIDE PERSONAL LUBRICANT
• Type of Device: LUBRICANT
• Manufacturer (Section D): BIOFILM
• MDR Report Key: 3602173
• MDR Text Key: 18730333
• Report Number: MW5034111
• Device Sequence Number: 2
• Product Code: KMJ
• 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: 01/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/01/2012
• Device Lot Number: A003304
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2014
• Patient Sequence Number: 1
• Treatment: CALCIUM; CARDIZEM; AVAPRO; FISH OIL; COMPOUNDED VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 75