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| Lot Number P17061501 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Pain (1994)
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Event Type
Death
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Event Description
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Committed suicide.Now has passed away [suicide].My mother developed gingivitis [gingivitis].She couldn't stand the pain because of gingivitis was painful and so unbearable her gums was very painful [gum pain].The gums began to shrink more and more [gingival recession].Alleviate the tooth ache [toothache].Case description: this case was reported by a consumer via call center representative and described the occurrence of suicide in a female patient who received denture cleanser (polident for partials denture cleanser tablets) tablet (batch number p17061501, expiry date 29th february 2020) for product used for unknown indication on an unknown date, the patient started polident for partials denture cleanser tablets.On an unknown date, an unknown time after starting polident for partials denture cleanser tablets, the patient experienced suicide (serious criteria death and gsk medically significant), gingivitis (serious criteria death), gum pain (serious criteria death), gingival recession, toothache and wrong technique in product usage process.The action taken with polident for partials denture cleanser tablets was unknown.On an unknown date, the outcome of the suicide, gingivitis and gum pain were fatal and the outcome of the gingival recession, toothache and wrong technique in product usage process were unknown.The reported cause of death was suicide.It was unknown if the reporter considered the suicide, gingivitis, gum pain, gingival recession and toothache to be related to polident for partials denture cleanser tablets.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information reported by a consumer via call center representative (phone) on 27feb2023.The reporter stated that, "my mother has used your polident denture cleanser tablets for several years, used including the large box of 60 tablets and the small box of 30 tablets.I would like to ask how often to use your this cleanser tablets.Your box only instructs to use one tablet to soak the dentures for 5 minutes or soak overnight, doesn't specify how often to use it once, every day or how often.At that time, after my mother had 4 dentures implanted and a few removable dentures installed, the doctor gave a few tablets of this cleanser tablets to my mother to clean the dentures, but didn't specify how often to use once, and we didn't ask, my mother use one tablet to soak every day, sometimes used half a tablet to soak, and sometimes my father only used water to soak my mother's dentures.About the year before last, found that my mother developed gingivitis, was painful and so unbearable, went to the dentist, the dentist said that it was ok to use this kind of cleanser tablets once every three months, and there was no need to use it every day.So how should we use it.Why is your packaging not marked.This year, my mother said that her gums was very painful, so went to the pharmacy, the staff of the pharmacy recommended anti inflammatory, to alleviate the tooth ache, after taking it, the gums began to shrink more and more.Later, she couldn't stand the pain because of gingivitis, and committed suicide, now has passed away.So i want to know whether corrosive force of your this cleanser tablets is very corrosive.I recently found out that a box of polident denture cleanser for partials 30 tablets pack product that my mother used and left before, has expired, the expiration date shown is: 29feb2020, and the batch number is: p17061501.Do you think corrosive force of your product is too strong.I just want to know if long-term use will hurt the nerves.If your product needs to be used under the guidance of a doctor, please don't make it can be bought casually in the supermarket, because i usually go to the supermarket to buy it for my mother, the doctor said that it should be used once every 3 months, you know.And didn't write clearly on your packaging".The consumer said that took "her mother to the dentist at that time, and the dentist just said that my mother was too honest to use one tablet a day, said that it was ok to use it once every three months.However, the dentist only said that it was gingivitis, and did not provide me with some doctor's certificates, in fact, i don't want to claim any expenses from you, but i just want to know three questions: 1.Does long-term use of polident denture cleanser tablets cause gingivitis to our gum 2.Will long-term use of polident denture cleanser tablets damage the gingival nerve3.For use instructions, is it better to soak for 5 minutes or overnight, and how long does it take to rinse off the cleanser of the cleanser tablets after soaking?".
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Manufacturer Narrative
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Argus case: (b)(4).
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Manufacturer Narrative
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Argus case id: (b)(4).
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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 suicide in a female patient who received denture cleanser (polident for partials denture cleanser tablets) tablet (batch number p17061501, expiry date 29th february 2020) for product used for unknown indication.On an unknown date, the patient started polident for partials denture cleanser tablets.On an unknown date, an unknown time after starting polident for partials denture cleanser tablets, the patient experienced suicide (serious criteria death and gsk medically significant), gingivitis (serious criteria death), gum pain (serious criteria death), gingival recession, toothache and wrong technique in product usage process.The action taken with polident for partials denture cleanser tablets was unknown.On an unknown date, the outcome of the suicide, gingivitis and gum pain were fatal and the outcome of the gingival recession, toothache and wrong technique in product usage process were unknown.The reported cause of death was suicide.It was unknown if the reporter considered the suicide, gingivitis, gum pain, gingival recession and toothache to be related to polident for partials denture cleanser tablets.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information reported by a consumer via call center representative (phone) on 27feb2023.The reporter stated that, "my mother has used your polident denture cleanser tablets for several years, used including the large box of 60 tablets and the small box of 30 tablets.I would like to ask how often to use your this cleanser tablets.Your box only instructs to use one tablet to soak the dentures for 5 minutes or soak overnight, doesn't specify how often to use it once, every day or how often.At that time, after my mother had 4 dentures implanted and a few removable dentures installed, the doctor gave a few tablets of this cleanser tablets to my mother to clean the dentures, but didn't specify how often to use once, and we didn't ask, my mother use one tablet to soak every day, sometimes used half a tablet to soak, and sometimes my father only used water to soak my mother's dentures.About the year before last, found that my mother developed gingivitis, was painful and so unbearable, went to the dentist, the dentist said that it was ok to use this kind of cleanser tablets once every three months, and there was no need to use it every day.So how should we use it.Why is your packaging not marked.This year, my mother said that her gums was very painful, so went to the pharmacy, the staff of the pharmacy recommended anti inflammatory, to alleviate the tooth ache, after taking it, the gums began to shrink more and more.Later, she couldn't stand the pain because of gingivitis, and committed suicide, now has passed away.So i want to know whether corrosive force of your this cleanser tablets is very corrosive.I recently found out that a box of polident denture cleanser for partials 30 tablets pack product that my mother used and left before, has expired, the expiration date shown is: 29feb2020, and the batch number is: p17061501.Do you think corrosive force of your product is too strong.I just want to know if long-term use will hurt the nerves.If your product needs to be used under the guidance of a doctor, please don't make it can be bought casually in the supermarket, because i usually go to the supermarket to buy it for my mother, the doctor said that it should be used once every 3 months, you know.And didn't write clearly on your packaging".The consumer said that took "her mother to the dentist at that time, and the dentist just said that my mother was too honest to use one tablet a day, said that it was ok to use it once every three months.However, the dentist only said that it was gingivitis, and did not provide me with some doctor's certificates, in fact, i don't want to claim any expenses from you, but i just want to know three questions: 1.Does long-term use of polident denture cleanser tablets cause gingivitis to our gum 2.Will long-term use of polident denture cleanser tablets damage the gingival nerve3.For use instructions, is it better to soak for 5 minutes or overnight, and how long does it take to rinse off the cleanser of the cleanser tablets after soaking?" follow up information was received by the consumer via telephone contact report on 04apr2023.It was reported as, "consumer said the patient had history of diabetes and depressive disorder, it was inconvenient to provide the doctor's contact information.Consumer suggested that manufacturer do extensive research, consult experts, and change the product label.Change the sales channel of the product to obtain it by doctor's prescription".Patient's medical history has been added as "diabetes and depressive disorder" and narrative updated.
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Search Alerts/Recalls
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