MAUDE Adverse Event Report: GLAXOSMITHKLIEN CONSUMER HEALTHCARE HOLDINGS (US) LLC. POLIDENT DENTURE CLEANER; CLEANSER, DENTURE OVER THE COUNTER

Lot Number 18C07RGC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Caustic/Chemical Burns (2549); Partial thickness (Second Degree) Burn (2694)

Event Date 08/21/2018

Event Type  Injury  

Event Description

My father soaked his dentures in polident when he woke up the next morning, his mouth was burning and had blisters inside of his mouth.He ended up in the er twice.His problem will never go away, he is (b)(6), a long story short.Chemical burn in mouth.Strength: clean in 5 min g gram(s).Quantity: 2 tablet(s); otc product.Dates of use: (b)(6) 2018.Reason for use: clean dentures.The dr said it was something in the polident.

Event Description

Additional info received from reporter on (b)(6) 2018 for report # mw5080190.I just wanted to add that my father is no better.I still have the product.I sent some to polident, they requested it.Now they are saying they didn't receive it.Just wanted to let you know the reason i didn't report to the fda, first i was told not to.

• Brand Name: POLIDENT DENTURE CLEANER
• Type of Device: CLEANSER, DENTURE OVER THE COUNTER
• Manufacturer (Section D): GLAXOSMITHKLIEN CONSUMER HEALTHCARE HOLDINGS (US) LLC.
• MDR Report Key: 7918721
• MDR Text Key: 122195425
• Report Number: MW5080190
• 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 Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/08/2019
• Device Lot Number: 18C07RGC
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 79 YR