| Device Problem
Product Quality Problem (1506)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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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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The saliva with the product is totally ingested/she ingested the product/product is totally ingested/ she ingests the product together with saliva/ because she was swallowing the ultra corega cream [accidental device ingestion].I even vomited [vomiting].I feel unwell [unwell].I felt unwell in my belly/ her belly became hard/ her belly hardens [abdominal discomfort].Pain in her belly [abdominal pain].Stomach pain [stomach pain].How many times do you use the product per day? 6 times daily/she has to use it for more than 4 times per day [device used for unapproved schedule].This case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received gsk denture adhesive (formulation unknown) (corega denture adhesive formulation unknown) unknown for product used for unknown indication.This case was associated with a product complaint.Concurrent medical conditions included tooth extraction and chronic pain (removed all her teeth due to a medication she took for chronic pain).On an unknown date, the patient started corega denture adhesive formulation unknown.On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and product complaint.The action taken with corega denture adhesive formulation unknown was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega denture adhesive formulation unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.About a year ago the patient removed all her teeth due to a medication she took for chronic pain.She ordered a corega cream sample and she bought corega powder; both products said that the fixing lasts until 12 hours.She saw some complaints and decided to ask for information and leave her opinion.She had been using corega cream for almost a year and the fixation never went beyond four hours, especially the inferior part.This made her very sad and upset, she felt cheated and she was afraid to use more than once out of necessity and cause some other health problem because the saliva with the product was totally ingested.She uses four or more tubes a month.She would like a clarification if it can do harm and why it doesn't last as long as it promises.Follow up received from consumer on 24 apr 2020: follow up dated 24 apr 2020, 28 apr 2020 and 30 apr 2020 were processed together.Co-suspect products included denture adhesive powder-double salt (corega powder) oral powder (batch number an9d, expiry date 31st july 2021) for prosthesis user, double salt dental adhesive cream (ultra corega cream without flavour) cream for denture wearer, double salt dental adhesive cream (ultra corega cream mint flavor) cream for denture wearer and omeprazole unknown for abdominal pain.Concurrent medical conditions included tooth extraction and chronic pain (removed all her teeth due to a medication she took for chronic pain).Concomitant products included methadone hydrochloride (methadone), morphine, duloxetine, chlorpromazine hydrochloride (longactil), clonazepam and gabapentin.On an unknown date, the patient started corega denture adhesive formulation unknown at an unknown dose and frequency.In (b)(6) 2020, the patient started corega powder.On an unknown date, the patient started ultra corega cream without flavour, ultra corega cream mint flavor and omeprazole at an unknown dose and frequency.On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, corega powder, ultra corega cream without flavour and ultra corega cream mint flavor, the patient experienced accidental device ingestion (serious criteria gsk medically significant), vomiting, unwell, abdominal discomfort, abdominal pain, device used for unapproved schedule, product complaint and lack of drug effect.The action taken with corega denture adhesive formulation unknown, ultra corega cream without flavour and ultra corega cream mint flavor was unknown.Therapy with corega powder was discontinued (dechallege: unknown).The action taken with omeprazole was unknown.On an unknown date, the outcome of the accidental device ingestion, device used for unapproved schedule, product complaint and lack of drug effect were unknown, the outcome of vomiting, unwell, abdominal discomfort was recovered/resolved and the outcome of the abdominal pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, vomiting, unwell, abdominal discomfort, abdominal pain and device used for unapproved schedule to be related to corega denture adhesive formulation unknown, corega powder, ultra corega cream without flavour and ultra corega cream mint flavor.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Patient used corega powder 6 times daily for prosthesis fixation.The patient informed that she used the product since (b)(6) of this year (2020) and after the first use, she had problems with the ungluing of the product.She ingested the product and reported with her own words that the powder did a dribble, as it was a gooey, it was awful.Patient even vomited, felt unwell, including, one of questions was if product was bad for some organs, because she felt unwell in belly.Follow up information was received on 28 april 2020 from the quality assurance (qa) department regarding complaint number (b)(4) for lot number unknown.The investigation reports concluded that, complaint stands inconclusive.Due to the absence of a lot number complaint, this register would be considered as ended by quality team.Follow up report received from consumer on 30 apr 2020: the reporter informed that she had been using the corega products since (b)(6) 2020, because she was using a medication, that made her teeth week, so she had to remove all her teeth and used a temporary prosthesis.She used ultra corega cream flavor mint and ultra corega cream without flavor and she used only twice the corega powder.The patient informed that the saliva with the product was totally ingested was related with the use of ultra corega cream flavor mint and ultra corega cream, and she informed that it still would happen.The patient informed that she had been using now the ultra corega cream flavor mint and it was not gluing, she had to use it for more than 4 times per day.She informed that she was having a pain in her belly, and she though that it could be related to the fact that she was using the product a lot.The patient informed that for her pain in the belly she had been using omeprazole and she informed that she was still presenting it.The patient informed that she only used corega powder for a few times, and that it formed a gooey in her mouth, and the first time she used , she felt unwell and the second time that she used it, she vomited, so she never used it, anymore.She did not presented these events anymore.Internal note: according to the product's instructions, the suspect product should be used once daily.Follow up information received on 12 may 2020 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for lot number an9d.Qa analysis revealed the complaint to be unsubstantiated (corega powder).All documentation associated with the manufacturing, packaging and testing of product was reviewed by the site quality department to verify compliance prior to product release.It was not found any observations that the problem could have been occurred within gsk.Follow up information was received from consumer on 21 may 2020, the saliva with the product was totally ingested/ pain in her belly.The patient reported that she used several very strong medications continuously because of a chronic pain she had and her belly became hard because she was swallowing the ultra corega cream, which she still used interchanging, she bought another fixer, cheaper and that lasts for all day.She could not go to the doctor to check the belly problem because of the pandemic.The patient was very upset, as she passed all the information to the call center and it was promised 9 corega products to her, but she only received 2, including a corega cream that the tube was pure liquid.The patient stated that she took omeprazole only on the day she had stomach pain as a treatment.She reiterated that when she uses ultra corega she felt that her belly hardens, she believe that it was because she ingests the product together with saliva.As she still had some units, it was still being used.The event stomach pain was added in the case.Follow up information was received on 01 jun 2020 from the quality assurance (qa) department regarding complaint number (b)(4) for lot number unknown.The investigation reports concluded that, complaint stands complaint inconclusive.The batch number was not informed by the consumer, and it was not possible to identify the presentation of the product, as well as the website for investigation.Thus, the complaint was closed by (b)(4) as inconclusive.
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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 accidental device ingestion in a female patient who received gsk denture adhesive (formulation unknown) (corega denture adhesive formulation unknown) unknown for product used for unknown indication.This case was associated with a product complaint.Concurrent medical conditions included tooth extraction and chronic pain (removed all her teeth due to a medication she took for chronic pain).On an unknown date, the patient started corega denture adhesive formulation unknown.On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, the patient experienced accidental device ingestion (serious criteria gsk medically significant) and product complaint.The action taken with corega denture adhesive formulation unknown was unknown.On an unknown date, the outcome of the accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega denture adhesive formulation unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details; about a year ago the patient removed all her teeth due to a medication she took for chronic pain.She ordered a corega cream sample and she bought corega powde; both products said that the fixing lasts until 12 hours.She saw some complaints and decided to ask for information and leave her opinion.She had been using corega cream for almost a year and the fixation never went beyond four hours, especially the inferior part.This made her very sad and upset, she felt cheated and she was afraid to use more than once out of necessity and cause some other health problem because the saliva with the product was totally ingested.She uses four or more tubes a month.She would like a clarification if it can do harm and why it doesn't last as long as it promises.Follow up received from consumer on 24 apr 20202: follow up dated 24 apr 2020, 28 apr 2020 and 30 apr 2020 were processed together.Co-suspect products included denture adhesive powder-double salt (corega powder) oral powder (batch number an9d, expiry date 31st july 2021) for prosthesis user, double salt dental adhesive cream (ultra corega cream without flavour) cream for denture wearer, double salt dental adhesive cream (ultra corega cream mint flavor) cream for denture wearer and omeprazole unknown for abdominal pain.Concurrent medical conditions included tooth extraction and chronic pain (removed all her teeth due to a medication she took for chronic pain).Concomitant products included methadone hydrochloride (methadone), morphine, duloxetine, chlorpromazine hydrochloride (longactil), clonazepam and gabapentin.On an unknown date, the patient started corega denture adhesive formulation unknown at an unknown dose and frequency.In (b)(6) 2020, the patient started corega powder.On an unknown date, the patient started ultra corega cream without flavour, ultra corega cream mint flavor and omeprazole at an unknown dose and frequency.On an unknown date, an unknown time after starting corega denture adhesive formulation unknown, corega powder, ultra corega cream without flavour and ultra corega cream mint flavor, the patient experienced accidental device ingestion (serious criteria gsk medically significant), vomiting, unwell, abdominal discomfort, abdominal pain, device used for unapproved schedule, product complaint and lack of drug effect.The action taken with corega denture adhesive formulation unknown, ultra corega cream without flavour and ultra corega cream mint flavor was unknown.Therapy with corega powder was dscontinued (dechallege: unknown).The action taken with omeprazole was unknown.On an unknown date, the outcome of the accidental device ingestion, device used for unapproved schedule, product complaint and lack of drug effect were unknown, the outcome of vomiting, unwell, abdominal discomfort was recovered/resolved and the outcome of the abdominal pain was not recovered/not resolved.It was unknown if the reporter considered the accidental device ingestion, vomiting, unwell, abdominal discomfort, abdominal pain and device used for unapproved schedule to be related to corega denture adhesive formulation unknown, corega powder, ultra corega cream without flavour and ultra corega cream mint flavor.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Patient used corega powder 6 times daily for prosthesis fixation.The patient informed that she used the product since february of this year (2020) and after the first use, she had problems with the ungluing of the product.She ingested the product and reported with her own words that the powder did a dribble, as it was a gooey, it was awful.Patient even vomited, felt unwell, including, one of questions was if product was bad for some organs, because she felt unwell in belly.Follow up information was received on 28 april 2020 from the quality assurance (qa) department regarding complaint number (b)(4) for lot number unknown.The investigation reports concluded that, complaint stands inconclusive.Due to the absence of a lot number complaint, this register would be considered as ended by quality team.Follow up report received from consumer on 30 apr 2020: the reporter informed that she had been using the corega products since (b)(6) 2020, because she was using a medication, that made her teeth week, so she had to remove all her teeth and used a temporary prosthesis.She used ultra corega cream flavor mint and ultra corega cream without flavor and she used only twice the corega powder.The patient informed that the saliva with the product was totally ingested was related with the use of ultra corega cream flavor mint and ultra corega cream, and she informed that it still would happen.The patient informed that she had been using now the ultra corega cream flavor mint and it was not gluing, she had to use it for more than 4 times per day.She informed that she was having a pain in her belly, and she though that it could be related to the fact that she was using the product a lot.The patient informed that for her pain in the belly she had been using omeprazole and she informed that she was still presenting it.The patient informed that she only used corega powder for a few times, and that it formed a gooey in her mouth, and the first time she used , she felt unwell and the second time that she used it, she vomited, so she never used it, anymore.She did not presented these events anymore.Internal note: according to the product's instructions, the suspect product should be used once daily.Follow up information received on 12 may 2020 from quality assurance (qa) department regarding complaint (b)(4) (issue number) for lot number an9d.Qa analysis revealed the complaint to be unsubstantiated (corega powder).All documentation associated with the manufacturing, packaging and testing of product was reviewed by the site quality department to verify compliance prior to product release.It was not found any observations that the problem could have been occurred within gsk.Follow up information was received from consumer on 21 may 2020, the saliva with the product was totally ingested/ pain in her belly.The patient reported that she used several very strong medications continuously because of a chronic pain she had and her belly became hard because she was swallowing the ultra corega cream, which she still used interchanging, she bought another fixer, cheaper and that lasts for all day.She could not go to the doctor to check the belly problem because of the pandemic.The patient was very upset, as she passed all the information to the call center and it was promised 9 corega products to her, but she only received 2, including a corega cream that the tube was pure liquid.The patient stated that she took omeprazole only on the day she had stomach pain as a treatment.She reiterated that when she uses ultra corega she felt that her belly hardens, she believe that it was because she ingests the product together with saliva.As she still had some units, it was still being used.The event stomach pain was added in the case.Follow up information was received on 01 jun 2020 from the quality assurance (qa) department regarding complaint number (b)(4) for lot number unknown.The investigation reports concluded that, complaint stands complaint inconclusive.The batch number was not informed by the consumer, and it was not possible to identify the presentation of the product, as well as the website for investigation.Thus, the complaint was closed by loc quality as inconclusive.Follow up information was received from consumer on 20 aug 2020: patient demographic was updated as 34 years old.It was reported that the saliva was completely ingested with the product and the patient also had pain in her belly.She was recovered from stomach pain, it was not a belly pain, it was stomach pain, but she continued to ingest corega with saliva.At the moment, patient was using corega together with fixodent and dentalfix.Follow up information was received on 02 sep 2020 from quality assurance (qa) department regarding complaint (b)(4) for an9d lot number.The results of the analysis of the claimed batch were evaluated and were in accordance with the product release trend.In particular the polyox test (which was the active ingredient that gave the product adhesion), tap density, ph and appearance due to altered consistency as well.The results were evaluated and were satisfactory as described below: band hit density- specification was 0.75 to 1.00 g/ml- result was 0.88 g/ml, poliox, specification was 17.8 to 24.2 percent and result was 19.3 percent, ph: specification: 7.3 to 9.5, result:8.3, aspect: white powder, light and free of weird material- result-satisfactory.There were no flaws in stability studies or oos for the product and no batches had been released with research not completed.It was worth mentioning that the amount of powder used for fixing the denture interferes with the product's effectiveness, so that a small amount made the product less viscous and a lot of it made the product very viscous, causing it to leak through the prosthesis.It should also be noted that in order to guarantee the quality of the product, it was necessary that the storage recommendations described on the product bottle must be strictly followed.They were: "store at room temperature.Protect from light and moisture." the annual review for the product super corega (corega low cost), for the year 2018, was consulted and, according to the provisions of the report, all physical-chemical results remain within the stability specifications when stored under the conditions long-term (monitoring) for the ivb climate zone.The results continued to support the expiration date, the declared storage conditions and the product release specifications.It was important to note that information on adverse events related to the use of corega powder was the responsibility of the gsk medical area.The claimed sample was received and evaluated by the complaints team.The packaging was violated and the powder was removed for a better visual evaluation, and it could be observed that it was in the form of white powder and that it flowed normally through the spigot.The presence of granules or blocking of the product was not observed.Following the sample test decision tree in sop- 207936, further tests were not necessary.For the above, this claim would be considered unfounded and no action was necessary.Qa analysis revealed the complaint to be unsubstantiated.
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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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