| Lot Number N56N |
| Device Problem
Product Quality Problem (1506)
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| Patient Problem
Choking (2464)
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Event Type
Injury
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Manufacturer Narrative
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Argus case: (b)(4).
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Event Description
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It makes me choke [choking].Now my gums are ulcerated [gum ulceration].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a male patient who received double salt dental adhesive cream (polident power max hold plus seal) cream (batch number: n56n, expiry date: october 2025) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started polident power max hold plus seal.In 2023, an unknown time after starting polident power max hold plus seal, the patient experienced choking (serious criteria haleon medically significant and other: haleon medically significant) and gum ulceration.On an unknown date, the patient experienced product complaint.The action taken with polident power max hold plus seal was unknown.On an unknown date, the outcome of the choking, gum ulceration and product complaint were unknown.The reporter considered the choking and gum ulceration to be related to polident power max hold plus seal.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 received from consumer via call center representative (phone) on (b)(6) 2023.It was reported that "whom i'm speaking to?.I rang up.I'm using one of your products.The polident power max hold + seal well, i've had an upper denture for quite a while.I've been using polident for years and years.And the month of those, i've found out that i'm using it, it's dissolving whether you have changed the recipe or whatever.It's not holding.I put it on about an hour ago i haven't had enough holding.And my top and bottom teeth lose quite a bit.And[?] this is why i rang up.I got the phone number on the box.I just don't know what's happening here.No, it's been happening for the last months, actually.My name is.Polident power max 12 hour hold max & seal + flavour-free partial denture adhesive.40g was at the supermarket.Mainly coles.It normally ranges (b)(6).No way.No, i thought it might imagination.And i clean my teeth regularly with the tablets.Like i've had enough.Without the glue, i can't eat.Now my gums are ulcerated.Cos they moved.Now i said, i'm gonna ring up and told you that this is unreal.I know where they change your recipe.Whatever.It's not even holding.And if they do come loose and i'll take it out or clean it.Normally there's some stuff still left in there.Now at the moment, it's like dissolving like there's nothing there.It's just dissolving.I try the mixture on.And all that doesn't seal out the sides and it makes me choke.It's been happening for over a month now.And it's very coincidental.I don't know when you change the recipe in or whatever.I can't continue on like this.Always buy 3 or 4.I got 3 in front of me now.So i do a lot of travelling on that account.Keep in the car.What can i say at the moment, it's like it's useless.I put on some an hour ago.And then my teeth loose.Normally it stays on until next day break normally.Where do you get the lot number from? the batch number is n56n.Expiry 2025/10 i'm gonna run out of a reception any minute.So i'm at the rush i'm at the country and then no reception showing.You got any more questions? it's just such a package.Made an outbound call on (b)(6) 2023 9:38 am.I gotta tell you.I'm in a bush in a country and then i run out of reception.And send it to where? an 1800 number? i ain't got email.I haven't got an email address.Well, it's not working.I don't know why? that's why i'll not use that one.You can't send it to my phone? you can't send me a text? i don't care about (b)(6).Something has happened to your product which is not working anymore.That's a waste of money.And i'm not worried about (b)(6).And your product is working for some reason now.Well, if you find out some, you can always ring me.You got my phone number.Unfortunately, i haven't got an email.I like you to ring me back and find out what's going on if you don't mind.Ther's something not right because i put it in my imagination.And it's been happening for a month now.I'm not home to look at the batch number now.I have an empty pack here and a batch number.I have another batch number, another one that i'm using which is nearly finished.G84e 2025/08 it's the same one.Polident max hold and seal.That's all i use.I'd been buying it every month.It's all that i use for the last 10 years.I used to use the other one and it's called (other brand) and i changed to this one years ago.Because it has alcohol in it.And alcohol stays in your mouth.That's why i changed to this one.It got alcohol-free.It used to work.But now it's not working.And obviously something has been changed so whatever in the ingredients.That has changed something in the ingredients to say it right now.It's been happening for over a month now.I just took my denture out now.It has dissolved now.In the past, if i take it out, you can still see the glue in there.Now, it is clear.It is not sticking.It has dissolved.Can you put it down to whoever makes it.And it's actually dissolving.It's a waste of money.No worries.
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Event Description
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Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a male patient who received double salt dental adhesive cream (polident power max hold plus seal) cream (batch number n56n, expiry date october 2025) for denture wearer.This case was associated with a product complaint.On an unknown date, the patient started polident power max hold plus seal.In 2023, an unknown time after starting polident power max hold plus seal, the patient experienced choking (serious criteria haleon medically significant and other: haleon medically significant) and gum ulceration.On an unknown date, the patient experienced product complaint.The action taken with polident power max hold plus seal was unknown.On an unknown date, the outcome of the choking, gum ulceration and product complaint were unknown.The reporter considered the choking and gum ulceration to be related to polident power max hold plus seal.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 received from consumer via call center representative (phone) on 25oct2023.It was reported that "whom i'm speaking to?.I rang up.I'm using one of your products.The polident power max hold + seal well, i've had an upper denture for quite a while.I've been using polident for years and years.And the month of those, i've found out that i'm using it, it's dissolving whether you have changed the recipe or whatever.It's not holding.I put it on about an hour ago i haven't had enough holding.And my top and bottom teeth lose quite a bit.And[?] this is why i rang up.I got the phone number on the box.I just don't know what's happening here.No, it's been happening for the last months, actually.My name is.Polident power max 12 hour hold max & seal + flavour-free partial denture adhesive.40g was at the supermarket.Mainly coles.It normally ranges 10 dollars - 11 dollars.No way.No, i thought it might imagination.And i clean my teeth regularly with the tablets.Like i've had enough.Without the glue, i can't eat.Now my gums are ulcerated.Cos they moved.Now i said, i'm gonna ring up and told you that this is unreal.I know where they change your recipe.Whatever.It's not even holding.And if they do come loose and i'll take it out or clean it.Normally there's some stuff still left in there.Now at the moment, it's like dissolving like there's nothing there.It's just dissolving.I try the mixture on.And all that doesn't seal out the sides and it makes me choke.It's been happening for over a month now.And it's very coincidental.I don't know when you change the recipe in or whatever.I can't continue on like this.Always buy 3 or 4.I got 3 in front of me now.So i do a lot of travelling on that account.Keep in the car.What can i say at the moment, it's like it's useless.I put on some an hour ago.And then my teeth loose.Normally it stays on until next day break normally.Where do you get the lot number from? the batch number is n56n.Expiry 2025/10 i'm gonna run out of a reception any minute.So i'm at the rush i'm at the country and then no reception showing.You got any more questions? it's just such a package.Made an outbound call on (b)(6) 2023 9:38 am.I gotta tell you.I'm in a bush in a country and then i run out of reception.And send it to where? an 1800 number? i ain't got email.I haven't got an email address.Well, it's not working.I don't know why? that's why i'll not use that one.You can't send it to my phone? you can't send me a text? i don't care about 11 dollars.Something has happened to your product which is not working anymore.That's a waste of money.And i'm not worried about 11dollars.And your product is working for some reason now.Well, if you find out some, you can always ring me.You got my phone number.Unfortunately, i haven't got an email.I like you to ring me back and find out what's going on if you don't mind.Ther's something not right because i put it in my imagination.And it's been happening for a month now.I'm not home to look at the batch number now.I have an empty pack here and a batch number.I have another batch number, another one that i'm using which is nearly finished.G84e 2025/08 it's the same one.Polident max hold and seal.That's all i use.I'd been buying it every month.It's all that i use for the last 10 years.I used to use the other one and it's called (other brand) and i changed to this one years ago.Because it has alcohol in it.And alcohol stays in your mouth.That's why i changed to this one.It got alcohol-free.It used to work.But now it's not working.And obviously something has been changed so whatever in the ingredients.That has changed something in the ingredients to say it right now.It's been happening for over a month now.I just took my denture out now.It has dissolved now.In the past, if i take it out, you can still see the glue in there.Now, it is clear.It is not sticking.It has dissolved.Can you put it down to whoever makes it.And it's actually dissolving.It's a waste of money.No worries.' follow up information was received on 30nov2023 from quality assurance(qa) department regarding complaint ((b)(4)) for lot number (n56n).Additional details was reported as milestone enacted to reflect the retain sample being recalled to site for qc testing.Investigational evaluation: this is the first complaint of this nature for this batch.The retain sample was recalled to site and sent to the lab for testing.The testing of the complaint retain sample has met the required quality standards.There is no quality, safety or efficacy issue associated with this lot.This complaint is deemed unsubstantiated and no further actions is required.Complaint conclusion: the investigational reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).
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Manufacturer Narrative
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Argus case: (b)(4).
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Search Alerts/Recalls
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