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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Liver Damage/Dysfunction (1954)
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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 liver was damaged, hepatic damage.It got stuck in her throat, too big to swallow down the throat, medication stuck in throat.Below the ribs was damaged as well, rib injury.Threw up 20 times; kept puking the whole day, vomiting.She didn't have sodium chloride when she had to have a lot - blood electrolytes decreased.She also got jaundice.Also shakes when speaking, she is shaking her hand and head, tremor.She got strange, weird feeling.Was speaking nonsense, incoherent.Case description: this case was reported by a consumer via call center representative and described the occurrence of hepatic damage in a 87-year-old female patient who received denture cleanser (polident 5min quick plus cleanser) tablet (batch number unknown, expiry date unknown) for product used for unknown indication.Previously administered products included omega 3 and beecom-c (beecom-c supplements).Additional patient notes included she didn't have dementia.On (b)(6) 2023, the patient started polident 5min quick plus cleanser.In (b)(6) 2023, less than a week after starting polident 5min quick plus cleanser, the patient experienced hepatic damage, serious criteria hospitalization and gsk medically significant, rib injury, serious criteria hospitalization and gsk medically significant, vomiting (serious criteria hospitalization), blood electrolytes decreased (serious criteria hospitalization), jaundice (serious criteria hospitalization) and tremor (serious criteria hospitalization).On (b)(6) 2023, the patient experienced medication stuck in throat (serious criteria hospitalization and gsk medically significant) and accidental ingestion of product (serious criteria hospitalization).The action taken with polident 5min quick plus cleanser was unknown.On an unknown date, the outcome of the hepatic damage, medication stuck in throat, rib injury, vomiting, blood electrolytes decreased, jaundice, tremor and accidental ingestion of product were unknown.It was unknown if the reporter considered the hepatic damage, rib injury, vomiting, blood electrolytes decreased, jaundice and tremor to be related to polident 5min quick plus cleanser.The reporter considered the medication stuck in throat to be related to polident 5min quick plus cleanser.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: the adverse event information was received from a consumer via call center representative (phone) on (b)(6) 2023.The consumer reported that, "the 87 years old mother swallowed a polident 5 minutes quick plus tablet by mistake.It got stuck in her throat so she drank a lot of water to make it go down.She swallowed yesterday dawn and threw up over 20 times.Called 911 and visited a hospital.Today she will get admitted to another hospital.She did a test and she didn't have sodium chloride when she had to have a lot.The liver was damaged, below the ribs was damaged as well.The liver test numbers were low and there was liver damage.She also got jaundice.She is shaking her hand and head.Also shakes when speaking.Before swallowing the pill, she did well and ate well.There were no issues in her health check last year and she didn't have dementia.After taking the cleanser, her whole body seems to be damaged.Took ct and mri.Because she is of old age, she is in the icu.Her doctor did not mention anything on the relationship with the polident yet.Illness / other medication : none.Only consumes omega 3 and beecom-c supplements".Follow up information was received from a consumer via call center representative (phone) on 26jan2023.It was reported that; "reporter's mother swallowed the polident cleanser.She thought it was her other medication.It was too big to swallow down the throat, but she forced it down.After taking the product, she kept puking the whole day, was speaking nonsense, and shaking her hands and face.She got strange.She is currently admitted at a hospital.When the reporter showed the doctors the product and told them that she swallowed this, they just said how could she swallow something so big and didn't say anything else.The doctors are not even caring about the cleanser.She got mri and ct scans, and the doctors only talks about the result.They seem to not care about the cleanser".As per follow up information extra event was added as incoherent and weird feeling.
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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 liver was damaged [hepatic damage].It got stuck in her throat, too big to swallow down the throat [medication stuck in throat].Below the ribs was damaged as well [rib injury].Threw up 20 times; kept puking the whole day [vomiting].She didn't have sodium chloride when she had to have a lot [blood electrolytes decreased].She also got jaundice [jaundice].Also shakes when speaking, she is shaking her hand and head; developed shaking of her hands [tremor].She got strange [weird feeling].Was speaking nonsense [incoherent].Swelling of the lungs [pulmonary edema].The 87 years old mother swallowed a polident 5 minutes quick plus tablet by mistake.[accidental ingestion of product].She confused it with another medication [product confusion].Liver measurements became elevated [raised liver function tests].Blood mixed in the urine [blood in urine].The organs crashed or broke down [organ failure].She became wobbly [unsteadiness].Case description: this case was reported by a consumer via call center representative and described the occurrence of hepatic damage in a 87-year-old female patient who received denture cleanser (polident 5min quick plus cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Previously administered products included omega 3 and beecom-c (beecom-c supplements).Additional patient notes included she didn't have dementia.On (b)(6) 2023, the patient started polident 5min quick plus cleanser.In (b)(6) 2023, less than a week after starting polident 5min quick plus cleanser, the patient experienced hepatic damage (serious criteria hospitalization and gsk medically significant), rib injury (serious criteria hospitalization and gsk medically significant), vomiting (serious criteria hospitalization), blood electrolytes decreased (serious criteria hospitalization), jaundice (serious criteria hospitalization) and tremor (serious criteria hospitalization).On (b)(6) 2023, the patient experienced medication stuck in throat (serious criteria hospitalization and gsk medically significant) and accidental ingestion of product (serious criteria hospitalization).The action taken with polident 5min quick plus cleanser was unknown.On an unknown date, the outcome of the hepatic damage, medication stuck in throat, rib injury, vomiting, blood electrolytes decreased, jaundice, tremor and accidental ingestion of product were unknown.It was unknown if the reporter considered the hepatic damage, rib injury, vomiting, blood electrolytes decreased, jaundice and tremor to be related to polident 5min quick plus cleanser.The reporter considered the medication stuck in throat to be related to polident 5min quick plus cleanser.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: the adverse event information was received from a consumer via call center representative (phone) on 20jan2023.The consumer reported that, "the 87 years old mother swallowed a polident 5 minutes quick plus tablet by mistake.It got stuck in her throat so she drank a lot of water to make it go down.She swallowed yesterday dawn and threw up over 20 times.Called 911 and visited a hospital.Today she will get admitted to another hospital.She did a test and she didn't have sodium chloride when she had to have a lot.The liver was damaged, below the ribs was damaged as well.The liver test numbers were low and there was liver damage.She also got jaundice.She is shaking her hand and head.Also shakes when speaking.Before swallowing the pill, she did well and ate well.There were no issues in her health check last year and she didn't have dementia.After taking the cleanser, her whole body seems to be damaged.Took ct and mri.Because she is of old age, she is in the icu.Her doctor did not mention anything on the relationship with the polident yet.Illness / other medication : none.Only consumes omega 3 and beecom-c supplements".Follow up information was received from a consumer via call center representative (phone) on 26jan2023.It was reported that; "reporter's mother swallowed the polident cleanser.She thought it was her other medication.It was too big to swallow down the throat, but she forced it down.After taking the product, she kept puking the whole day, was speaking nonsense, and shaking her hands and face.She got strange.She is currently admitted at a hospital.When the reporter showed the doctors the product and told them that she swallowed this, they just said how could she swallow something so big and didn't say anything else.The doctors are not even caring about the cleanser.She got mri and ct scans, and the doctors only talks about the result.They seem to not care about the cleanser." as per follow up information extra event was added as incoherent and weird feeling.Follow up information was received from a consumer via call center representative on 27feb2023.It is reported that, "the reporter's mother is 87 years old and on 19th january, she confused it with another medication and took/ingested polident cleanser, and she vomited for the whole day, liver measurements became elevated, experienced swelling of the lungs and blood mixed in the urine and the organs crashed/ broke down.She was alright even until the day before, but after taking/ingesting the cleanser, she became wobbly, developed shaking of her hands and was even hospitalised.The doctors don't know that polident cleanser is so toxic that it can render a body like this.Discarded the product." added lab test results.The action taken with the suspect polident was updated as withdrawn with dechallenge unknown.Added patient route of administration as oral for the suspect polident.Added events raised liver function tests, pulmonary edema, blood in urine, organ failure and unsteadiness with onset date 2023, outcome unknown, causality yes and tto onset from first dose less than a month.Added event product confusion with onset date 19jan2023, outcome unknown, seriousness hospitalization and causality unknown.Updated the causality of the events hepatic damage, rib injury, vomiting, blood electrolytes decreased, jaundice, tremor, weird feeling, and incoherent as yes.Causality of the event accidental ingestion of product was updated as unknown.In 2023, liver function test result was elevated.The reporter considered the hepatic damage, rib injury, vomiting, blood electrolytes decreased, jaundice, tremor, weird feeling, incoherent, pulmonary edema, raised liver function tests, blood in urine, organ failure and unsteadiness to be related to polident 5min quick plus cleanser.
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Search Alerts/Recalls
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