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Hand was bleeding [hemorrhage].It is toxic [device toxicity].It irritates my hand [arm discomfort].My lip break out [eruption facial].Case description: this case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a female patient who received denture cleanser foam (polident propartial foam cleanser) cleanser (batch number 3380a1, expiry date 30th november 2023) for dental cleaning.This case was associated with a product complaint.On (b)(6) 2021, the patient started polident propartial foam cleanser.On an unknown date, an unknown time after starting polident propartial foam cleanser, the patient experienced hemorrhage (serious criteria gsk medically significant and other: gsk medically significant), device toxicity, arm discomfort, eruption facial and product complaint.The action taken with polident propartial foam cleanser was unknown.On an unknown date, the outcome of the hemorrhage, device toxicity, arm discomfort, eruption facial and product complaint were unknown.The reporter considered the hemorrhage, arm discomfort and eruption facial to be related to polident propartial foam cleanser.It was unknown if the reporter considered the device toxicity to be related to polident propartial foam cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was reported by consumer via call center representative (phone) on (b)(6) 2021.The consumer reported that "i am calling about the polident for partials pro cleaner its terrible its toxic and i really wish you had bring back the tablets.I have had to use it because i have nothing else to use my partial is made out of metal with the teeth on it and it is terrible, it is terrible it does not table the stain off like the tablet and i cannot use the regular because it compromises the metal, i have to cover my hands when i use it because it irritates my hand, my hand was bleeding and i realized what was causing it, i have to rinse it like five times, i have had my lip break out because of it, i have not been able to find the tablets and it's horrible it took the stains off and it did not comprise the partial and i cannot afford to replace the partial.That is one refund and there is nothing else you can use.So, there is nothing else on the market and it is a shame that you had to change it.I have seen reviews and have also said it is toxic because it is.It is different because i need to have more.Let me tell you what, and i see i bought the wrong thing, i bought the one for the retainer, so i have to go buy another for your partial and it wasn't just this stuff it was happening before i got it.I think the other one that i had went out in the trash last week." this is 1 of 2 cases which is linked with case number (b)(4) (same reporter) follow up information received on (b)(6) 2021 from quality assurance (qa) department regarding product quality complaint (b)(4) with reference id (b)(4) with lot number 3380a1.Product (sample) was no longer available for return (discarded).
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Case description: this case was reported by a consumer via call center representative and described the occurrence of hemorrhage in a female patient who received denture cleanser foam (polident propartial foam cleanser) cleanser (batch number 3380a1, expiry date 30th november 2023) for dental cleaning.This case was associated with a product complaint.On (b)(6) 2021, the patient started polident propartial foam cleanser.On an unknown date, an unknown time after starting polident propartial foam cleanser, the patient experienced hemorrhage (serious criteria gsk medically significant and other: gsk medically significant), device toxicity, arm discomfort, eruption facial and product complaint.The action taken with polident propartial foam cleanser was unknown.On an unknown date, the outcome of the hemorrhage, device toxicity, arm discomfort, eruption facial and product complaint were unknown.The reporter considered the hemorrhage, arm discomfort and eruption facial to be related to polident propartial foam cleanser.It was unknown if the reporter considered the device toxicity to be related to polident propartial foam cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was reported by consumer via call center representative (phone) on (b)(6) 2021.The consumer reported that "i am calling about the polident for partials pro cleaner its terrible its toxic and i really wish you had bring back the tablets.I have had to use it because i have nothing else to use my partial is made out of metal with the teeth on it and it is terrible, it is terrible it does not table the stain off like the tablet and i cannot use the regular because it compromises the metal, i have to cover my hands when i use it because it irritates my hand, my hand was bleeding and i realized what was causing it, i have to rinse it like five times, i have had my lip break out because of it, i have not been able to find the tablets and it's horrible it took the stains off and it did not comprise the partial and i cannot afford to replace the partial.That is one refund and there is nothing else you can use.So, there is nothing else on the market and it is a shame that you had to change it.I have seen reviews and have also said it is toxic because it is.It is different because i need to have more.Let me tell you what, and i see i bought the wrong thing, i bought the one for the retainer, so i have to go buy another for your partial and it wasn't just this stuff it was happening before i got it.I think the other one that i had went out in the trash last week." this is 1 of 2 cases which is linked with case number (b)(4) (same reporter) follow up information received on 02dec2021 from quality assurance (qa) department regarding product quality complaint (b)(4) with reference id (b)(4) with lot number 3380a1.Product (sample) was no longer available for return (discarded).Follow up information was obtained on 16dec2021 from quality assurance (qa) department regarding complaint (b)(4) and (b)(4) for lot number 3380a1.The complaint was concluded as unsubstantiated.The report says that, "the retain evaluation did not confirm the nature of complaint.125ml polident po gaurd and reatiner fg 24ct 60000000128765, lot 3380a1 met all required release specifications at the time of manufacture and prior to shipping.Based on the conducted investigation, it can be concluded that the quality of the product is assured without affecting the safety and integrity of the product.Certificate of analysis of the finished goods passed inspection upon release of the product.The lot was manufactured and packaged in accordance with the current and correct specifications and released by the quality department.Based on the above conclusions, there is no reason to believe tat the adverse event experienced by the customer was due to the quality factor of the product.Moreover it should be noted that each person may respond differently to active ingredients depending on their physiological conditions.Based on the information provided in the investigation, the complaint is not substantiated.Tracking and trending of this issue is ongoing." follow up information was obtained on 16dec2021 from quality assurance (qa) department regarding complaint (b)(4) for lot number 3380a1 regarding the investigational site.The complaint sample was not available for evaluation.It is no longer available for return (discarded) an end retain sample was submitted to laboratory se/vices for testing:: ph specification: 4.2 - 5.8 ph results: pass, ph 5.05 these specifications are set by gsk.Prior to release, the finished goods were tested for ph.A passing result of 5.1 was generated.Retain samples were not tested for performance (cleaning) as there is no testing parameter in the specification to confirm this part of the complaint.Based on review of the manufacturing batch record, all raw materials were present, in the correct quantity, and in an approved status {met specifications).There are no quality events (recall notices) associated with this bulk, finished good part number or lot.The manufacturing processing suite was in compliance as per cgmp and applicable procedures.All equipment had been cleaned and was within labeled calibration dates and in good working condition.Packaging daily equipment/area checks: start of shift were verified at the start of each shift.These area checks include but are not limited to; packaging equipment and line purged of product previously packaged, area clean, correct product/components, and verify 20 mesh in-line gasket filter installed at infeed of buffer tank prior to release, the finished goods were tested for appearance (dispensed product), appearance {undisturbed), ph, and specific gravity.All finished goods met specifications.The retain evaluation did not confirm the nature of complaint.125ml polident pro guard and retainer fg 24ct 60000000128765, lot 3380a1 met all required release specifications at the time of manufacture and prior to shipping.Based on the conducted investigation, it can be concluded that the quality of the product is assured without affecting the safety and integrity of the product.Certificate of analysis of the finished goods passed inspection upon release of this product.The lot was manufactured and packaged in accordance with the current and correct specifications and released by the quality department.Based on the above conclusions, there is no reason to believe that the adverse event experienced by the customer was due to the quality factor of the product.Moreover, it should be noted that each person may respond differently to active ingredients depending on their physiological conditions.Based on the information provided in this investigation, this complaint is not substantiated, tracking and trending of this issue is ongoing.The investigation reports concluded the complaint as an unsubstantiated.
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