MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT CUSHION AND COMFORT DENTURE ADHESIVE CREAM

Lot Number 063090

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 03/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Burned in 3rd degree the upper gum [third degree burns].Burned in 3rd degree the inside of the nose [burn of nose].Burned in 3rd degree the upper inner lip [burning lips].Burned in 3rd degree the labial frenum [burning mouth.] a burn [burn].Painful [pain].Trouble eating [eating disorder].As well as stinging in the tongue and inside the nose [stinging tongue].As well as stinging in the tongue and inside the nose [nasal stinging].Labial frenum where there is still a small blister.[blistering of mouth].Case description: this case was reported by a consumer via call center representative and described the occurrence of third degree burns in a (b)(6) female patient who received double salt dental adhesive cream (polident cushion and comfort denture adhesive cream) cream (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident cushion and comfort denture adhesive cream and no therapy at an unknown dose and frequency.On an unknown date, an unknown time after starting polident cushion and comfort denture adhesive cream, the patient experienced third degree burns (serious criteria gsk medically significant), burn of nose, burning lips, burning mouth, burn, pain and eating disorder.The action taken with polident cushion and comfort denture adhesive cream was unknown.The action taken with no therapy was unknown.On an unknown date, the outcome of the third degree burns was recovering/resolving and the outcome of the burn of nose, burning lips, burning mouth, burn, pain and eating disorder were unknown.It was unknown if the reporter considered the third degree burns, burn of nose, burning lips, burning mouth, burn, pain and eating disorder to be related to polident cushion and comfort denture adhesive cream.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: this case was reported by a consumer via call center representative (email) on 07 apr 2021.The consumer reported that "i sent an email to the patient to give me the details we need.Hello i wanted to point out that your product: amorti et confort from polident burned in 3rd degree the upper gum as well as the inside of the nose, the upper inner lip and the labial frenum, it is not an allergy as you indicate on the tube in warning and precautions but rather a burn.It is very painful, and the mouthwashes do nothing about it! i also have trouble eating.The pain is only starting to go, it would have lasted 10 days.I've already used other fixative gels of your brand and it's gone well, so it's only with this one that there's a problem (i think)".The follow up information was received on 08 apr 2021 stated that "i am (b)(6), my phone number is the lot number is 063090 and the expiry date is 01/2023.I used this product twice a day (like the products i used before) i started using this product around (b)(6) 2021, the symptoms started on (b)(6) 2021, i stopped using immediately (the same day) and the symptoms increased day by day, i did mouthwashes (bought in a pharmacy) thinking it was apthae, but no improvements, even though a little relief due to cold water.I had the gum, the labial frenum and the inside of the upper lip all red and burning, as well as stinging in the tongue and inside the nose.It's been better since yesterday ((b)(6)) but it's not completely healed especially at the labial frenum where there is still a small blister." the initial and follow up information were processed together.

• Brand Name: POLIDENT CUSHION AND COMFORT DENTURE ADHESIVE CREAM
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 11783296
• MDR Text Key: 249247410
• Report Number: 3003721894-2021-00130
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 04/07/2021

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: Lay User/Patient
• Device Lot Number: 063090
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR