| Lot Number 16M349RGC |
| Device Problem
Material Discolored (1170)
|
| Patient Problem
Itching Sensation (1943)
|
|
Event Type
Injury
|
|
Manufacturer Narrative
|
|
3005372036-2018-00002 is associated with argus id (b)(4), polident tablets 84 count.Qa results: a complaint sample was not returned for evaluation.A batch record review of lot 16m349rgc was performed.There were no issues found during this review.Manufacture of this lot took place under normal operating conditions.There were no nonconformances noted within the batch record.All ingredients were appropriately charged into the batch.Product was confirmed to have met all pre-established product specifications all raw materials were tested and met specification requirements and released prior to use in manufacturing operations.Review of raw material trend data confirms that there have been no issues reported during use of these materials.Nonconformance review for this lot confirmed that there has been no manufacturing/facility issues related to this complaint that would affect the production of polident denture cleanser tablets.A retain sample for the lot was visually inspected and found to be acceptable.Color off: a review of complaint trend data confirms this is the third complaint received for tablet discoloration.This is the first complaint for lot 16m349rgc, the other complaints were for different lots and were not confirmed.Dissolution: a review of complaint trend data confirms this is the one-hundredth complaint for effervescence issues.This is the first complaint for lot 16m349rgc, the other complaints were for different lots and were not confirmed.Review of nonconformance data confirms there have been no nonconformances to date regarding missing tablets of polident denture cleansers.The complaint was unconfirmed.Product met all in process and analytical testing specification at time of release.All testing performed on the retain sample met specification.
|
| |
|
Event Description
|
|
Hospitalization [hospitalization].Suicidal tendency/ the patient felt like she almost died [suicidal tendency].Suicidal tendency/ the patient felt like she almost died [impending doom].Mental impairment/ spirit torture [mental impairment].Generalized itch [generalized pruritus].Nose itching [nasal itching].Skin allergy [allergic skin reaction].She couldn't help scratching, until bleeding [scratch].She couldn't help scratching, until bleeding [skin bleeding].Caused skin damaged [skin disorder].Poor appetite [appetite impaired].Agitated or whiny mood [mood change].Agitated or whiny mood [agitation].She was afflicted both physically and psychologically [discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a (b)(6) -year-old female patient who received denture cleanser (polident denture cleanser) tablet for denture wearer.This case was associated with a product complaint.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced generalized pruritus, allergic skin reaction, tablet split incorrectly, suspected counterfeit product, product complaint, scratch, skin bleeding and discomfort.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the generalized pruritus and allergic skin reaction were not reported and the outcome of the tablet split incorrectly, suspected counterfeit product, product complaint, scratch, skin bleeding and discomfort were unknown.The reporter considered the generalized pruritus and allergic skin reaction to be related to polident denture cleanser.It was unknown if the reporter considered the scratch, skin bleeding and discomfort to be related to polident denture cleanser.Additional details, one female consumer used one box of polident denture cleanser for full (60 tablets/box, details unk), which was purchased from a pharmacy by her son.She was (b)(6) -year-old currently and had full mouth dentures.When using it, she found some cleanser tablets had colours on both sides with white and green but other tablets were white on both sides.These white cleanser tablets were not effervescent in water and the colour of its solution was still white and didn't change.Therefore, the consumer used 2 tablets once to soak her dentures and suspected this product was counterfeit.Suspected counterfeit product and product complaint were both reported.5-6 years ago, the consumer started polident denture cleanser (details unk) by using half a tablet every evening to soak her dentures (product use by splitting the tablet, unk intentional or accidental).After this soak, her dentures were fragrant.After polident denture cleanser was used, she developed generalized itch as skin allergy every day all year round.Unspecified adhesive bandage, unguent, vaseline and bb oil were purchased and used for her condition before but without any effect.Recently, the reporter bought baochailing (non-gsk product) for her to use.The consumer visited a hospital previously and no issue was found from her blood tests.There was also no any finding in other examinations.She had itchy skin before using polident denture cleanser but it was different from current generalized itch.Originally, she experienced itch only when the weather was hot and there was no feeling in winter.She felt comfortable once the air conditioner was turned on.The reporter stated the patient usually ate rice and chicken relatively more but it couldn't cause allergy.Hence, he thought the consumer's skin allergy was associated with using polident denture cleanser.Her skin was so itchy that she couldn't help scratching, until bleeding.She was afflicted both physically and psychologically.Follow up received on (b)(6) 2018 from qa department.The qa analysis revealed the complaint to be unsubstantiated.Follow up information was received on 30 may 2018, there were less than 4 to 5 plates in unused stage of this box of polident denture cleanser.Quality assurance report revealed that the product complaint to be unsubstantiated.Follow up was received on 11 jun 2018.The case was reported by a consumer via call center representative and described the occurrence of hospitalization in a (b)(6) -year-old female patient who received denture cleanser (polident denture cleanser) tablet (batch number p17041401, expiry date 30th november 2019) and (batch number 16m349rgc, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, the dose was changed to an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant), suicidal tendency (serious criteria gsk medically significant), impending doom (serious criteria gsk medically significant), mental impairment (serious criteria gsk medically significant), generalized pruritus, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint.Polident denture cleanser was discontinued (dechallenge was unknown).On an unknown date, the outcome of the hospitalization, suicidal tendency, impending doom, mental impairment, generalized pruritus, allergic skin reaction, appetite impaired, mood change and agitation were recovered/resolved and the outcome of the scratch, skin bleeding, skin disorder, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint were unknown.It was unknown if the reporter considered the hospitalization, suicidal tendency, impending doom, mental impairment, generalized pruritus, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation and discomfort to be related to polident denture cleanser.Follow ups for (b)(6) 2018 were processed together.The patient had stopped polident denture cleanser and then allergy condition was obviously improved.The skin allergy caused the patient to experience spirit torture (huge mental impairment), she had no appetite, was agitated or had whiny mood.The patient scratched her skin, causing skin damage.The patient uninterruptedly used unspecific drugs (ointment and baochai ointment) to work against itch feeling and unspecific hemostatic sticker for damaged skin.The patient used ointment and hemostatic sticker every day.It was hard to express the patient's spirit torture (mental impairment) in simple words.The patient had suicidal tendency before and was stopped by her family members.The patient felt the label was not clear or accurate about skin allergy and not enough information was showed on the label.Follow up was received from quality assurance department on (b)(6) 2018.As there was no information about itching in product label, it was not known to the reporter if the adverse events were related to polident denture cleanser.The patient was more than 80 years old.She miserably suffered from the mental impairment caused by the adverse events.The itching was so itchy that it resulted in skin bleeding and almost made the patient to die.She got itching on hands and feet.She had bought ointment and stanch plasters.She had been hospitalized, reason of which was not provided.She had had blood tests done, but no reason was found out.The product was withdrawn and the patient was basically okay (outcomes of adverse events were selected as "recovered").7 tablets of polident denture cleanser for full (60s) were received by quality assurance as investigation sample on 19 jun 2018, batch number of which was p17041401, expiration date was 30 nov 2019.A note paper was sent along with the sample, which said there were 2 kinds of cleansers inside.Cleansers in white color did not effervesce and cleansers in bright color effervesced slightly, not obvious effervescence was seen previously.The old patient got generalized itching.Additional information was received from quality assurance department on 19 jun 2018.For polident denture cleanser for full (60s), its primary package lot number was 16m349rgc with p17041401 as its secondary package lot number.Follow up was received from quality assurance department on 20 jun 2018.Qa analysis revealed the complaint to be unsubstantiated.Follow up was received on 21 jun 2018.Polident denture cleanser was discontinued (dechallenge was unknown).Rechallenge was positive.The consumer had bought polident denture cleanser for full (60s).The consumer did not dare to use it.The previous product effervesced.The product did not effervesce and was of 2 colors.Later, the consumer got allergy again.This report is being resubmitted to capture corrections.The information was received on 21 jun 2018 and is as follows: for polident denture cleanser for full (60s), its primary package lot number was 16m349rgc with p17041401 as its secondary package lot number.This report is being resubmitted to capture corrections.The information was received on 21 jun 2018 and is as follows: based on the lot number provided for polident and the manufacturer provided in the qa investigation, the product was manufactured by pharmatech (not block drug).The product has just now been configured.Follow up was received on 09 jul 2018.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident tablets 84 count.On an unknown date, an unknown time after starting polident tablets 84 count, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant), suicidal tendency (serious criteria gsk medically significant), impending doom (serious criteria gsk medically significant), mental impairment (serious criteria gsk medically significant), generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint.On an unknown date, the outcome of the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, allergic skin reaction, appetite impaired, mood change and agitation were recovered/resolved and the outcome of the nasal itching was recovering/resolving and the outcome of the scratch, skin bleeding, skin disorder, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint were unknown.It was unknown if the reporter considered the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation and discomfort to be related to polident tablets 84 count.The consumer had used denture cleansers for years.She had got nose itching.The suspect drug had been withdrawn.Then the symptom got obvious improvement.This report is being resubmitted to capture corrections.The information was received on 20 jun 2018 and is as follows: the follow up receipt date was changed to 20 jun 2018 (date of the qa results).It was wrongly captured before as 21 jun 2018.
|
| |
|
Event Description
|
|
Case description: this case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a 89-year-old female patient who received denture cleanser (polident denture cleanser) tablet for denture wearer.This case was associated with a product complaint.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced generalized pruritus, allergic skin reaction, tablet split incorrectly, suspected counterfeit product, product complaint, scratch, skin bleeding and discomfort.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the generalized pruritus and allergic skin reaction were not reported and the outcome of the tablet split incorrectly, suspected counterfeit product, product complaint, scratch, skin bleeding and discomfort were unknown.The reporter considered the generalized pruritus and allergic skin reaction to be related to polident denture cleanser.It was unknown if the reporter considered the scratch, skin bleeding and discomfort to be related to polident denture cleanser.Additional details, one female consumer used one box of polident denture cleanser for full (60 tablets/box, details unk), which was purchased from a pharmacy by her son.She was 89-year-old currently and had full mouth dentures.When using it, she found some cleanser tablets had colours on both sides with white and green but other tablets were white on both sides.These white cleanser tablets were not effervescent in water and the colour of its solution was still white and didn't change.Therefore, the consumer used 2 tablets once to soak her dentures and suspected this product was counterfeit.Suspected counterfeit product and product complaint were both reported.5-6 years ago, the consumer started polident denture cleanser (details unk) by using half a tablet every evening to soak her dentures (product use by splitting the tablet, unk intentional or accidental).After this soak, her dentures were fragrant.After polident denture cleanser was used, she developed generalized itch as skin allergy every day all year round.Unspecified adhesive bandage, unguent, vaseline and bb oil were purchased and used for her condition before but without any effect.Recently, the reporter bought baochailing (non-gsk product) for her to use.The consumer visited a hospital previously and no issue was found from her blood tests.There was also no any finding in other examinations.She had itchy skin before using polident denture cleanser but it was different from current generalized itch.Originally, she experienced itch only when the weather was hot and there was no feeling in winter.She felt comfortable once the air conditioner was turned on.The reporter stated the patient usually ate rice and chicken relatively more but it couldn't cause allergy.Hence, he thought the consumer's skin allergy was associated with using polident denture cleanser.Her skin was so itchy that she couldn't help scratching, until bleeding.She was afflicted both physically and psychologically.Follow up received on 30 may 2018 from qa department.The qa analysis revealed the complaint to be unsubstantiated.Follow up information was received on 30 may 2018, there were less than 4 to 5 plates in unused stage of this box of polident denture cleanser.Quality assurance report revealed that the product complaint to be unsubstantiated.Follow up was received on 11 jun 2018.The case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 89-year-old female patient who received denture cleanser (polident denture cleanser) tablet (batch number p17041401, expiry date 30th november 2019) and (batch number 16m349rgc, expiry date unknown) for denture wearer.This case was associated with a product complaint.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, the dose was changed to an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant), suicidal tendency (serious criteria gsk medically significant), impending doom (serious criteria gsk medically significant), mental impairment (serious criteria gsk medically significant), generalized pruritus, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint.Polident denture cleanser was discontinued (dechallenge was unknown).On an unknown date, the outcome of the hospitalization, suicidal tendency, impending doom, mental impairment, generalized pruritus, allergic skin reaction, appetite impaired, mood change and agitation were recovered/resolved and the outcome of the scratch, skin bleeding, skin disorder, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint were unknown.It was unknown if the reporter considered the hospitalization, suicidal tendency, impending doom, mental impairment, generalized pruritus, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation and discomfort to be related to polident denture cleanser.Follow ups for (b)(6) 2018 were processed together.The patient had stopped polident denture cleanser and then allergy condition was obviously improved.The skin allergy caused the patient to experience spirit torture (huge mental impairment), she had no appetite, was agitated or had whiny mood.The patient scratched her skin, causing skin damage.The patient uninterruptedly used unspecific drugs (ointment and baochai ointment) to work against itch feeling and unspecific hemostatic sticker for damaged skin.The patient used ointment and hemostatic sticker every day.It was hard to express the patient's spirit torture (mental impairment) in simple words.The patient had suicidal tendency before and was stopped by her family members.The patient felt the label was not clear or accurate about skin allergy and not enough information was showed on the label.Follow up was received from quality assurance department on 19 jun 2018.As there was no information about itching in product label, it was not known to the reporter if the adverse events were related to polident denture cleanser.The patient was more than 80 years old.She miserably suffered from the mental impairment caused by the adverse events.The itching was so itchy that it resulted in skin bleeding and almost made the patient to die.She got itching on hands and feet.She had bought ointment and stanch plasters.She had been hospitalized, reason of which was not provided.She had blood tests done, but no reason was found out.The product was withdrawn and the patient was basically okay (outcomes of adverse events were selected as "recovered").7 tablets of polident denture cleanser for full (60s) were received by quality assurance as investigation sample on 19 jun 2018, batch number of which was p17041401, expiration date was 30 nov 2019.A note paper was sent along with the sample, which said there were 2 kinds of cleansers inside.Cleansers in white color did not effervesce and cleansers in bright color effervesced slightly, not obvious effervescence was seen previously.The old patient got generalized itching.Additional information was received from quality assurance department on 19 jun 2018.For polident denture cleanser for full (60s), its primary package lot number was 16m349rgc with p17041401 as its secondary package lot number.Follow up was received from quality assurance department on 20 jun 2018.Qa analysis revealed the complaint to be unsubstantiated.Follow up was received on 21 jun 2018.Polident denture cleanser was discontinued (dechallenge was unknown).Rechallenge was positive.The consumer had bought polident denture cleanser for full (60s).The consumer did not dare to use it.The previous product effervesced.The product did not effervesce and was of 2 colors.Later, the consumer got allergy again.This report is being resubmitted to capture corrections.The information was received on 21 jun 2018 and is as follows: for polident denture cleanser for full (60s), its primary package lot number was 16m349rgc with p17041401 as its secondary package lot number.This report is being resubmitted to capture corrections.The information was received on 21 jun 2018 and is as follows: based on the lot number provided for polident and the manufacturer provided in the qa investigation, the product was manufactured by pharmatech (not block drug).The product has just now been configured.Follow up was received on 09 jul 2018.Concurrent medical conditions included drug allergy.On an unknown date, the patient started polident tablets 84 count.On an unknown date, an unknown time after starting polident tablets 84 count, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant), suicidal tendency (serious criteria gsk medically significant), impending doom (serious criteria gsk medically significant), mental impairment (serious criteria gsk medically significant), generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint.On an unknown date, the outcome of the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, allergic skin reaction, appetite impaired, mood change and agitation were recovered/resolved and the outcome of the nasal itching was recovering/resolving and the outcome of the scratch, skin bleeding, skin disorder, discomfort, tablet split incorrectly, suspected counterfeit product and product complaint were unknown.It was unknown if the reporter considered the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation and discomfort to be related to polident tablets 84 count.The consumer had used denture cleansers for years.She had got nose itching.The suspect drug had been withdrawn.Then the symptom got obvious improvement.This report is being resubmitted to capture corrections.The information was received on 20 jun 2018 and is as follows: the follow up receipt date was changed to 20 jun 2018 (date of the qa results).It was wrongly captured before as 21 jun 2018.Follow up information was received on 13 jul 2018: polident denture cleanser was discontinued (dechallenge was positive).On an unknown date, the outcome of the scratch and skin bleeding were recovered/resolved and the outcome of the generalized itching was not recovered/not resolved.The reporter (the consumer's son) complained of unclear description of the local label.The consumer would be 90 years old on (b)(6) 2018.She had kept using polident denture cleanser for several years, at least 4,5 years.The consumer experienced a continuous itch severely, which made her want to die almost.The consumer was afflicted both physically and psychologically.This report was being resubmitted to capture corrections.The information was received on 13 jul 2018 and was as follows: the manufacturer of the suspect drug polident denture cleanser was updated to pharmatech as pti royston (initially wrongly reported as block drug co., inc.).Follow up information was received on 13 jul 2018: this case was reported by a consumer via call center representative and described the occurrence of hospitalization in a 89-year-old female patient who received denture cleanser (polident denture cleanser) tablet for denture wearer.This case was associated with a product complaint.Concurrent medical conditions included drug allergy (aspirin).On an unknown date, the patient started polident denture cleanser.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant), suicidal tendency (serious criteria gsk medically significant), impending doom (serious criteria gsk medically significant), mental impairment (serious criteria gsk medically significant), generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation, discomfort, suspected counterfeit product, product complaint, lack of drug effect and wrong technique in product usage process.Polident denture cleanser was discontinued (dechallenge was positive).On an unknown date, the outcome of the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, allergic skin reaction, scratch, skin bleeding, appetite impaired, mood change and agitation were recovered/resolved and the outcome of the nasal itching was recovering/resolving and the outcome of the skin disorder, discomfort, suspected counterfeit product, product complaint, lack of drug effect and wrong technique in product usage process were unknown.It was unknown if the reporter considered the hospitalization, suicidal tendency, impending doom, mental impairment, generalized itching, nasal itching, allergic skin reaction, scratch, skin bleeding, skin disorder, appetite impaired, mood change, agitation and discomfort to be related to polident denture cleanser.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Follow up information was received on 17 jul 2018: on an unknown date, an unknown time after starting polident denture cleanser, the patient experienced wrong technique in product usage process and lack of drug effect.On an unknown date, the outcome of the wrong technique in product usage process and lack of drug effect were unknown.The consumer stated polident denture cleanser only had a little effervescence and suspected this was counterfeit.The normal product would effervesce when it was put into water, but this product could not effervesce, even the consumer had put more than one tablet.The consumer did not remember whether one side was white and the other side was green or two sides were white.When the polident denture cleanser could not effervesce, the consumer would put more than one tablet in the water for cleaning denture (incorrect using method, polident the consumer felt the product had no effect (lack of effect).Normally, the consumer used one tablet of polident denture cleanser for cleaning denture.Follow-up information received on 25 jul 2018.The consumer had used polident denture cleanser according to product label.Neither outer or inner package included detailed description about allergy.The ambiguity made most of the consumers unable to understand the package instruction.The consumer was not sure if adverse events were induced by polident previously.The adverse events recovered after withdrawal of polident.The consumer had consulted doctor, had hospitalized, had made blood test, no problem was found.This report was being resubmitted to capture corrections.The information was received on 17 jul 2018 and was as follows: the manufacturer of the suspect drug polident denture cleanser was updated to pharmatech as pti royston (initially wrongly reported as block drug co., inc.).
|
| |
|
Manufacturer Narrative
|
|
Mdr report is associated with argus id (b)(4), polident tablets 84 count.
|
| |
|
Search Alerts/Recalls
|
|
