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He got colitis [colitis] stomach health problem [stomach discomfort] intestinal problem [gastrointestinal disorder] case description: this case was reported by a consumer via call center representative and described the occurrence of colitis in a 72-year-old male patient who received double salt dental adhesive cream (ultra corega max hold + seal) cream (batch number dx2h2, expiry date june 2026) for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2023, the patient started ultra corega max hold + seal.On (b)(6) 2023, less than a week after starting ultra corega max hold + seal, the patient experienced stomach discomfort and gastrointestinal disorder.In (b)(6) 2023, the patient experienced product complaint.On (b)(6) 2023, the patient experienced colitis (serious criteria haleon medically significant and other: haleon medically significant).The action taken with ultra corega max hold + seal was unknown.On (b)(6) 2023, the outcome of the stomach discomfort and gastrointestinal disorder were unknown.On an unknown date, the outcome of the colitis and product complaint were unknown.The reporter considered the colitis, stomach discomfort and gastrointestinal disorder to be related to ultra corega max hold + 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 19dec2023.It was reported that " my name is (b)(6), it happens that a few days ago i bought a corega to glue prostheses, he has been using corega for 4 years; it turns out that this corega did not fix, my husband had a stomach health problem.He is the only one who has an intestinal problem and we blame the corega, it looks like a gummy ball, i saw the expiration date and still the texture it is different, it does not last, it does not adhere, it does not manage to harden, yesterday he put on the prosthesis and he got colitis.The product is ultra corega max hold plus seal no flavor.12 hours of fixation, 70gr, i called you from (b)(6) batch number is dx2h2 expiration date 06/2026 used it for 4 days, the color of the container is a little different from the previous one, it has lilac, yellow and light brown colors, today it is already my husband didn't use it, but he had a bad night".Follow up information received from quality assurance department on 20dec2023.Product complaint (b)(4) was voided due to pqc logged in error.Initial and follow up was processed together.The information was received on 19dec2023 and the correction is as follows: imdrf code for event product complaint was added.
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Case description: this case was reported by a consumer via call center representative and described the occurrence of colitis in a 72-year-old male patient who received double salt dental adhesive cream (ultra corega max hold + seal) cream (batch number dx2h2, expiry date june 2026) for drug use for unknown indication.This case was associated with a product complaint.In (b)(6) 2023 the patient started ultra corega max hold + seal.On (b)(6) 2023 less than a week after starting ultra corega max hold + seal, the patient experienced stomach discomfort and gastrointestinal disorder.In (b)(6) 2023 the patient experienced product complaint.On 18th (b)(6) 2023 the patient experienced colitis (serious criteria haleon medically significant and other: haleon medically significant).The action taken with ultra corega max hold + seal was unknown.On (b)(6) 2023 the outcome of the stomach discomfort and gastrointestinal disorder were unknown.On an unknown date, the outcome of the colitis and product complaint were unknown.The reporter considered the colitis, stomach discomfort and gastrointestinal disorder to be related to ultra corega max hold + 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 19dec2023.It was reported that " my name is (b)(6) it happens that a few days ago i bought a corega to glue prostheses, he has been using corega for 4 years; it turns out that this corega did not fix, my husband had a stomach health problem.He is the only one who has an intestinal problem and we blame the corega, it looks like a gummy ball, i saw the expiration date and still the texture it is different, it does not last, it does not adhere, it does not manage to harden, yesterday he put on the prosthesis and he got colitis.The product is ultra corega max hold plus seal no flavor.12 hours of fixation, 70gr, i called you from (b)(6) batch number is dx2h2 expiration date 06/2026 used it for 4 days, the color of the container is a little different from the previous one, it has lilac, yellow and light brown colors, today it is already my husband didn't use it, but he had a bad night".Follow up information received from quality assurance department on 20dec2023.Product complaint (b)(4) was voided due to pqc logged in error.Initial and follow up was processed together.The information was received on 19dec2023 and the correction is as follows: imdrf code for event product complaint was added.Follow up information was received on 04jan2024 from quality assurance department (qa) regarding complaint (b)(4) and case number (b)(4) (lot no.Dx2h).As per the investigation report, the steps of the process that could have affected the adhesive capacity of the adhesion of the batch are relieved: potential causes put an x as it corresponds justification for eliminated cause, root cause, contributive cause controls in process.The review of the control in the performed process during the packaging of the batch were performed, designed to detect and minimize anomalies in relation with the aspect and integrity of the product, without finding the reported anomalies.Between the controls performed prior to the packaging it has to be mentioned: description/appearance/viscosity.It is important to mentioned that the dental adhesive creams are formulated to generate an hermetic seal and provide firm fixation for dental prosthesis.The combination of the main components of the product which are gantrez and carboxi methyl cellulose provide the adhesive force that helps to keep the dental prosthesis in place.Fq assays with the purpose of assure the product quality adhesive force assays are performed on the batches of ultra corega cream flavor free and mint flavor.Those assays are found in the stablished parameters.The physic chemical assays performed for the release of the batch, it has to be mentioned appearance/ viscosity/ separation/ adhesive force satisfactorily comply with the specifications.Hermetic knob during the packaging of the batch the following controls were performed to guarantee the hermeticity and integrity of the knobs: aspect of the knobs, as established qd-sop-030780 frequency: 30 min.Knob without dirt, legible impression.Correct crimp.To control 10 consecutives units of a box at the end of the packaging line.Hermeticity, as established qd-sop-030780.Frequency: 60 min.Put the knob in the hermeticity measurer.During 6 seconds the system applies a pressure of 1.4kg/cm2 at minimum.Specification: no cream must exit through the sealed zone for the assay to be satisfactory.All the controls complied with the specifications.The parameters of sealing of the knobs like voltage, potence and intensity of the system of high frequency are fixed and cannot be modified thanks to the filler which has different access levels.Excursion of temperature during the adding of mineral il and petrolatum.The documentation associated to the used batch is relieved.It is included in the bc, the verification of the temperature of mineral oil and petrolatum prior to their adding, although it has to be mentioned that in case of not being in temperature the scada system would block the addition of such materials.Lack of mixture during the production of the batch.The parameters of agitation are defined by recipe, additionally there are verification and manual scrapping steps of the walls of the tank after the adding of the powder to guarantee the homogenization of the mixture components.In the investigation the steps of bc are relieved, it is observed that all complied in the associated batches.Screw cap in bad state.During the analysis of the material of the used packaging the control method mme011 such parameters were verified.For the packaging of the batch dx2h the following knob batches were used: 62000000070704 est u corega ss max seal 70g, 0002301978, 0002284558.The performed controls to the packaging materials complied with the specifications no reports were performed with parameters outside specification or observations and there are no complains nor deviations associated to the material batch of packaging.Batch exposed to room conditions of humidity outside specification the room is connected to a verification system of continued humidity and temperature that has an alarm to notify in case such parameters are outside of the established limits.No values were registered outside the specification for the humidity value.Lack of final homogenization of the batch.This is related with the speed of the rotor, caudal and gap of the mill which the paste goes through in the final steps of the elaboration.Such parameters were not modified being maintained used in the rest of the manufactured batch.Review of the associated documentation: the review of the associated documentation associated to the product and the batch was performed.In the batchcard no abnormalities were registered related to the productive process and all the operations of manufactured and packaging were performed according to the stablished steps.All the materials associated to the manufacture of the batch are approved.With the end to assure that the quality of the product is kept throughout its useful life, there are studies of stability that guarantee that the parameter of adhesion is kept throughout all its useful life, when the product is conserved in the recommended storage conditions (conserved room temperature (less than 30 degree c) in dry place) on the other hand it is expected that the consumer has different experiences based on individuals factors, like the texture or appearance of the cream and adjust/ placing of the dental prosthesis.For that reason it is important to follow the conditions of storage of the product and the instructions of application, indicated in the art of the product as: conserve the room temperature (less than 30 degree c) in dry place.To apply: 1 clean and dry your prosthesis, 2 apply corega in little stripes, not very close to the borders of the prosthesis, like it is shown in the picture (which can be found in the package).3 wash your mouth before placing the prosthesis.4 place the prosthesis correctly in the mouth and press firmly for a few seconds to assure fixation.No abnormalities nor observations in the controls in the performed process.The user did not send a picture as evidence of the complain.During the research of the material of packaging it is verified that package used was corega max seal 70g corega ss max seal 70g (62000000070707) batch 0002293575.The same corresponds to such presentation.No deviations were registered for the batch no history was registered for the batch and defect complain product does not hold/ product consistency or texture is uncharacteristic -cpc tex off.It is considered complain not proved.Response to consumer (if applicable): an investigation was performed by operational quality, based on the review of the documentation.The manufacturing operation was conducted following the steps defined in the batchcard and all the ipcs performed during the packaging met specifications.All raw materials used in the manufacture of bulk product were approved.This kind of complaint is related to different individual factors associated with dental prosthesis.If consumers improperly place the dental prosthesis, especially leaving a space between them and the cream, is possible that the product cannot reach the expected adhesiveness.Additionally, the consumer is expected to have different experiences based on various individual factors, such as the adjustment / placement of dental prostheses and their oral anatomy, which can determine the performance of dental adhesive creams.Also, it is very important to respect the storage conditions indicated in the product's art (keep the container tightly closed.Store at room temperature (lessthan 30 degree c) in a dry place).For the above, it is concluded that the present complaint is unsubstantiated.Follow up information was received on 04jan2024 from quality assurance department (qa) regarding complaint (b)(4) and case number (b)(4) (lot no.Dx2h).Response to consumer (if applicable): an investigation was performed by operational quality, based on the review of the documentation.The manufacturing operation was conducted following the steps defined in the batchcard and all the ipcs performed during the packaging met specifications.All raw materials used in the manufacture of bulk product were approved.This kind of complaint is related to different individual factors associated with dental prosthesis.If consumers improperly place the dental prosthesis, especially leaving a space between them and the cream, is possible that the product cannot reach the expected adhesiveness.Additionally, the consumer is expected to have different experiences based on various individual factors, such as the adjustment / placement of dental prostheses and their oral anatomy, which can determine the performance of dental adhesive creams.Also, it is very important to respect the storage conditions indicated in the product's art (keep the container tightly closed.Store at room temperature (lessthan 30 degree c) in a dry place).For the above, it is concluded that the present complaint is unsubstantiated.
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