MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT DENTURE ADHESIVE, FLAVOR FREE

Lot Number XA9U

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

Patient Problem Stroke/CVA (1770)

Event Type  Injury  

Event Description

Before the stroke a few years ago, my father could put on the dentures by himself [stroke].He is not really able to talk now [speech disorder].Now his swallowing function is not very good [swallowing disorder].Filled the adhesive into the grooves of the dentures, we use a lot of adhesive, use a cotton swab to help him apply [wrong technique in device usage process].Used repeatedly many times like this [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of stroke in a elderly male patient who received double salt dental adhesive cream (polident denture adhesive, flavor free) cream (batch number xa9u, expiry date january 2026) for denture wearer.Concurrent medical conditions included nasogastric tube feeding (on a nasogastric tube, so he did not eat or drink).On an unknown date, the patient started polident denture adhesive, flavor free.On an unknown date, an unknown time after starting polident denture adhesive, flavor free, the patient experienced stroke (serious criteria haleon medically significant), speech disorder, swallowing disorder, wrong technique in device usage process and device used for unapproved schedule.The action taken with polident denture adhesive, flavor free was unknown.On an unknown date, the outcome of the stroke, speech disorder, swallowing disorder, wrong technique in device usage process and device used for unapproved schedule were unknown.It was unknown if the reporter considered the stroke, speech disorder, swallowing disorder, wrong technique in device usage process and device used for unapproved schedule to be related to polident denture adhesive, flavor free.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received from consumer via call center representative (phone) on 11aug2023.The consumer reported that, "my father is elderly and does not have teeth, he uses whole mouth removable dentures.We go to buy polident denture adhesive to help him fix his dentures, but now the dentures on the upper jaw do not stick no matter what, will drop down, don't know how to deal with it.We use polident denture adhesive flavour free 70g.My father's dentures have been used for a very long time; it has been installed for around 5 years.Before the stroke a few years ago, my father could put on the dentures by himself, and he has used the adhesive for a long time, he usually bought it from due to the stroke, we help him stick it on now, it doesn't stick after trying many times.Previously, my father filled the adhesive into the grooves of the dentures, then put them on.Because of the stroke now, it is not convenient to move, not convenient to go out, did not go back to the dentist.I followed your instructions for use, such as the mouth should be moistened first, i used a mung bean sized dot of adhesive on my father's denture and put it on, it could stick a bit at the start, but it fell off not long later.In this course of events where dentures were put on and could not stick and fell off, my father did not eat or drink, because he is now on a nasogastric tube, so he did not eat or drink, just simply hopes that he can fix on the dentures.I do not have the carton instructions at hand now.Before putting it on, should the mouth and gums be moistened or kept dry? are 3 dots enough for the upper jaw groove? my father would fill the entire groove with adhesive before putting it on last time, if it is just 3 dots, can it stick? after squeezing on the adhesive, i didn't apply it evenly in the groove.Have to rinse the mouth right? because it is not convenient for my father to rinse the mouth, now there was stroke, he is not able to clean his mouth by himself, i use a cotton swab to help him apply, we use the adhesive like this.After putting it on, is it okay to bite and hold for 1 minute? we tried many times, and used a lot of adhesive, and we realized it does not really stick.The upper denture falls off easily due to gravity, used a lot of adhesive to stick on, it falls off not long later, used repeatedly many times like this, so there is this problem.You said that the gum will atrophy, why will it atrophy? can i ask about the cleaning part? after the dentures are removed, there will still be adhesive left on the gums in the mouth, we use a toothbrush dipped in warm water to slowly brush it down, is this method correct? we are scared that he will choke, so we did not do gargling action, our family member uses a toothbrush to brush the adhesive down, now his swallowing function is not very good, will easily choke if he gargles, not able to gargle.We have to work very hard to help him clean, he is not really able to talk now.If for example we don't clean it well, there is a bit of residue left, will there be any effect on the body if it is accidentally eaten? sku: polident denture adhesive flavour free 70g.Lot: xa9u.Exp: 202601.".

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIDENT DENTURE ADHESIVE, FLAVOR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road, suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17683318
• MDR Text Key: 322638659
• Report Number: 3003721894-2023-00150
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2023

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: XA9U
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/05/2023
• 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
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Sex: Male