MAUDE Adverse Event Report: GLAXOSMITHKLINE CONSUMER HEALTHCARE POLIDENT 3 MINUTE DENTURE CLEANSER

Lot Number MD191724A

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Tissue Damage (2104)

Event Date 04/29/2018

Event Type  Injury  

Event Description

I have been using polident cleansing tablets exactly as directed, once a day to clean a dental appliance.I began to notice cheilitis on my lips, especially one deep cut with no known origin that took a week to heal.I used a different cleanser for several days, but used polident again last night and slept in my dental device after rinsing it thoroughly.I woke up with several cuts on the inside of my mouth on my gums, and peeling skin inside of my mouth.This dental appliance has not caused me any abrasions or discomfort until i began using polident.I plan to avoid products containing potassium monopersulfate in the future, but wanted to add my experience to the record.Primary: yes.Product type: drug/biologic.Is the product compounded: yes.Is the product over-the-counter: yes.Did the problem stop after the person reduced the dose or stopped taking or using the product: yes.Did the problem return if the person started taking or using the product again: yes.Do you still have the product in case we need to evaluate it: yes.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.Why was the person using the product: to clean a dental appliance.

• Brand Name: POLIDENT 3 MINUTE DENTURE CLEANSER
• Type of Device: POLIDENT 3 MINUTE DENTURE CLEANSER
• Manufacturer (Section D): GLAXOSMITHKLINE CONSUMER HEALTHCARE
• MDR Report Key: 7482411
• MDR Text Key: 107328744
• Report Number: MW5076975
• Device Sequence Number: 1
• Product Code: EFT
• 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: 04/30/2018

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
• Device Lot Number: MD191724A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 54