MAUDE Adverse Event Report: GSK CONSUMER HEALTHCARE HOLDINGS (US) LLC POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER; CLEANSER, DENTURE, OVER THE COUNTER

Device Problem Naturally Worn (2988)

Patient Problems Hemorrhage/Bleeding (1888); Burning Sensation (2146)

Event Date 02/16/2020

Event Type  Injury  

Event Description

Since october had been using polident 4 min daily cleanser as directed on a dental device, i wear at night as recommended by my dental office.Experienced burning sensation on my tongue and tongue bleeding for several weeks.Symptoms resolved after discontinuing use of polident for cleaning.I used polident again once to clean my device and experienced same symptoms after one night of wear.

• Brand Name: POLIDENT ANTIBACTERIAL DENTURE CLEANSER 3 MINUTE DAILY CLEANSER
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): GSK CONSUMER HEALTHCARE HOLDINGS (US) LLC
• MDR Report Key: 9733559
• MDR Text Key: 180610999
• Report Number: MW5093129
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): Y
• 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: 02/17/2020

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?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/19/2020
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 59