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It gets caught in my throat with my food.[medication stuck in throat].All it does is bleed out [hemorrhage].Case description: this case was reported by a consumer via call center representative and described the occurrence of medication stuck in throat in a patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint on an unknown date, the patient started poligrip flavour free.On an unknown date, an unknown time after starting poligrip flavour free, the patient experienced medication stuck in throat (serious criteria haleon medically significant), hemorrhage and product complaint.The action taken with poligrip flavour free was unknown.On an unknown date, the outcome of the medication stuck in throat, hemorrhage and product complaint were unknown.The reporter considered the medication stuck in throat to be related to poligrip flavour free.It was unknown if the reporter considered the hemorrhage to be related to poligrip flavour 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 by consumer via call center representative (phone) on 30nov2023.The consumer reported," i have a complaint.It is regarding the poligrip.It is worse.All it does is bleed out.It is the green one.I see changes in the ingredients.It doesn't work and it gets caught in my throat with my food.I have had a lot of doctors and no one can do anything about it, i have a flat palette.I don't like the new formula.I have power hold and seal and it is baloney.It doesn't hold at all.I have tried them all and they don't work.It literally disintegrates.I can send a picture of it via email.Please also send me the questions".Suspect drug: poligrip flavor free denture adhesive cream unknown size.Follow up information was received on 30nov2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.Investigation evaluation: the complaints received for cpc ooze are of a common/ expected nature for the fixative paste formulations and are classified as oozing complaints.Oozing of the product occurs when excessive products is applied to the denture.Directions for each tube state to use the minimum amount necessary to get maximum hold without having product ooze from the dentures (ref risk analysis section technical files).(b)(4) complaints were received between 01st november 2019 and 31st october 2021 for cpc ooze with an average of (b)(4) complaints per month.This represents a decrease in the average number of complaints received when compared to previous trending performed 01st jan 2018 to 31st of december 2018, where an average of (b)(4) complaints per month were received.Reference the 24-month trend chart for this defect in figure 5.1 and figure 5.2 below.All documentation pertinent to a specific lot number of finished product is kept in a single [?]batch envelope'.Prior to disposition of the product, the contents of each envelope are reviewed and approved by the site quality department to verify compliance to required release specifications.Complaints will continue to be analyzed monthly for any developing adverse trends and reported at quality council where it will be determined if further action is necessary.Denture adhesive cream with this defect does not pose any risk to the customer.Response to consumer: this product was manufactured to the required standards and met all requirements of the release specification.Oozing of the product occurs when excessive product is applied to the denture.Directions for each tube state to use the minimum amount necessary to get maximum hold without having product ooze from the dentures.Please be assured that this complaint has been logged, will be indicated in the manufacturing site metrics and all be brought to the attention of all relevant site personnel as part of the monthly complaint review process.On the basis of the above i now wish to consider this complaint closed please revert should you require any further information the investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).Follow up information was received on 30nov2023 from quality assurance (qa) department regarding product quality complaint with case number (b)(4) for unknown lot number.Investigation evaluation: denture adhesive creams are specially formulated to form a tight seal and provide a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provides the adhesive strength that helps hold dentures in place.Haleon denture adhesives have been shown to be effective in providing 12 hours hold across multiple randomized clinical trials.The complaints received for the reason code cpe dnt hold are of a common expected nature for the fixative paste formulations.Prior to the generation of a cim, each cpe dnt hold customer complaint was individually investigated whereby the complaint sample was tested for the percentage of active ingredient.A batch documentation review was also performed to verify that there were no issues during the manufacture or packaging of the batch.Each investigation verified that the concentration of active material was within specification and that the product had been manufactured appropriately and complied with all required quality standards.Response to consumer: the concentration of ingredient in the lot/product in question was within specification and met all requirements of the release specification.All of the documentation pertinent to a specific lot of finished product is contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.As with any product, it is expected that the consumer may have different experiences based on various individual factors like the fit of the denture and the oral anatomy of the denture wearer, that may determine the performance of the denture adhesive.Please be assured that this complaint has been logged, will be indicated in the manufacturing site metrics and will be brought to the attention of all relevant site personnel as part of the complaint review process.On the basis of the above i now wish to consider this complaint closed please revert should you require any further information the investigation reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).Initial and follow up processed together.Follow up information was received on 8dec2023 from quality assurance(qa) department regarding complaint ((b)(4)) for lot number (unknown).Investigational evaluation: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information is not available the complaint cannot be substantiated and will be closed as inconclusive.If the consumer contacts us with additional information or if the complaint sample is received, the complaint issue will be reopened and further evaluated.The investigational reports concluded that, complaint stands inconclusive.The pqc number was reported as (b)(4).
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