MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT (UNKNOWN); DENTURE CLEANSER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fainting (1847); Fall (1848); Renal Failure (2041); Respiratory Distress (2045); Transient Ischemic Attack (2109); Vertigo (2134); Loss of Vision (2139); Vomiting (2144); Weakness (2145); Twitching (2172); Numbness (2415); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682); Test Result (2695)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

This report is associated with argus case (b)(4), polident (unknown).

Event Description

Another stroke, kidneys shutting down [renal disorder], lack of vision, increased cough, presyncope, twitching, heat in neck, intermittent weakness in right arm, vomiting, numbness, worsened mobility status, lack of balance, falls, easily disorientated, low phosphate, elevated creatinine.Case description: this case was reported by a consumer via call center representative and described the occurrence of stroke in a (b)(6) male patient who received double salt dental adhesive cream (poligrip strong hold denture adhesive cream) cream for denture wearer.Co-suspect products included polident (polident (unknown)) unknown for drug use for unknown indication.The patient's past medical history included cancer (cancer survivor), heart attack, stroke and impaired quality of life.Concurrent medical conditions included paralysis, blind, denture wearer, glaucoma (diagnosed 14 years ago), retinal detachment (left eye), cough, mobility decreased, drug allergy and pollen allergy.On an unknown date, the patient started poligrip strong hold denture adhesive cream and polident (unknown).On (b)(6) 2016, an unknown time after starting poligrip strong hold denture adhesive cream and polident (unknown), the patient experienced stroke (serious criteria hospitalization and gsk medically significant), cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting and numbness.In (b)(6) 2016, the patient experienced renal disorder (serious criteria gsk medically significant).On an unknown date, the patient experienced loss of vision (serious criteria gsk medically significant), mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased.The patient was treated with phosphate.On an unknown date, the outcome of the stroke, renal disorder, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness and mobility decreased were not reported and the outcome of the loss of vision, balance disorder, fall, disorientation, phosphate decreased and creatinine increased were unknown.It was unknown if the reporter considered the stroke, renal disorder, loss of vision, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness, mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased to be related to poligrip strong hold denture adhesive cream and polident (unknown).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: in (b)(6) 2016 he was "again ambulanced to hospital with another stroke and learned that [his] kidneys are shutting down." the consumer indicated that a few years ago he had to have his top teeth removed and dentures to replace them.He has been using a full large tube of poligrip strong hold denture adhesive cream per week.The consumer has now been told that his bottom teeth are all being removed over the next 10 days, meaning that will be two tubes of poligrip strong hold denture adhesive cream per week and polident.The consumer also provided his emergency services (ems) report from (b)(6) 2016 as an email attachment.According to this report, the consumer reported catching something from a cat.According to the triage note, the consumer complained of increased cough, presyncope, twitching, heat in neck, intermittent weakness in right arm, and vomiting with emesis twice.He was diagnosed with numbness.Blood work revealed low phosphate and elevated creatinine (see lab values section for details).500 mg of oral phosphate was ordered for the consumer.Upon discharge, the consumer was advised to follow up with his family doctor in 7 days for phosphate level and kidney function.The consumer was also referred to a clinic.Consumer revealed that he was diagnosed with glaucoma 14 years ago and lost [vision in his] left eye and was told it was a matter of time before he lost sight in his right eye.When he first learned that he was losing sight and had his driver's license taken away, he felt that he lost all independence, all ability to go out, to socialize, to work, to function at all.The consumer became part of an organization that taught him how to cook again, he was able to look after his 90 year old father, they taught him how to label food, label clothes to match, taught him braille, and how to use a computer which is something he'd never done.He would not be working and travelling if not for this organization.Prior to joining he had a low quality of life, now he loves his life and wouldn't trade it with anyone he meets.In a referral request to the clinic mentioned above by the consumer's ophthalmologist.According to the referral form, the consumer's field of vision is less than 20 degrees diameter in both eyes.His right eye vision is 20/60.The ophthalmologist attributes vision loss in the right and left eyes to glaucoma and stroke.The ophthalmologist indicates that from his understanding, the consumer has had strokes in the past year which have further worsened his mobility status.The report also states that due to the consumer's lack of vision and balance, he often falls.He gets easily disoriented and gets lost.Follow-up information received via phone call on 31-jan-2017: consumer called to confirm that cancer, strokes, heart attacks, and any other adverse event issues happened prior to the use of poligrip strong hold denture adhesive cream and polident.The consumer indicated that nothing is wrong with the product except the expensive retails price.Additional follow-up received from consumer via phone call on 02-feb-2017: consumer was called back in regards to the last trip to the hospital in (b)(6) 2016 related to "another stroke" and "kidneys shutting down." consumer confirmed that he uses poligrip strong hold denture adhesive cream and polident on a daily basis for almost 3 to 4 years.The consumer also stated that he does not have the knowledge to make the connection between the stroke and kidneys shutting down in (b)(6) 2016 to the use of the products.

Manufacturer Narrative

This report is associated with argus case (b)(4), polident (unknown) qa results: no sample received and no lot number given.No complaints have been received for any of the polident variants pertaining to causing a stroke for the consumer.The product is not to be ingested nor is the solution to be used as a mouthwash.The product is safe to use when used as directed on the package instructions.The complaint was unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of stroke in a (b)(6) male patient who received double salt dental adhesive cream (poligrip strong hold denture adhesive cream) cream for denture wearer.Co-suspect products included polident (polident (unknown)) unknown for drug use for unknown indication.The patient's past medical history included cancer (cancer survivor), heart attack, stroke and impaired quality of life.Concurrent medical conditions included paralysis, blind, denture wearer, glaucoma (diagnosed 14 years ago), retinal detachment (left eye), cough, mobility decreased, drug allergy and pollen allergy.On an unknown date, the patient started poligrip strong hold denture adhesive cream and polident (unknown).On (b)(6) 2016, an unknown time after starting poligrip strong hold denture adhesive cream and polident (unknown), the patient experienced stroke (serious criteria hospitalization and gsk medically significant), cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting and numbness.In (b)(6) 2016, the patient experienced renal disorder (serious criteria gsk medically significant).On an unknown date, the patient experienced loss of vision (serious criteria gsk medically significant), mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased.The patient was treated with phosphate.On an unknown date, the outcome of the stroke, renal disorder, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness and mobility decreased were not reported and the outcome of the loss of vision, balance disorder, fall, disorientation, phosphate decreased and creatinine increased were unknown.It was unknown if the reporter considered the stroke, renal disorder, loss of vision, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness, mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased to be related to poligrip strong hold denture adhesive cream and polident (unknown).Additional information: in (b)(6) 2016 he was "again ambulanced to hospital with another stroke and learned that [his] kidneys are shutting down." the consumer indicated that a few years ago he had to have his top teeth removed and dentures to replace them.He has been using a full large tube of poligrip strong hold denture adhesive cream per week.The consumer has now been told that his bottom teeth are all being removed over the next 10 days, meaning that will be two tubes of poligrip strong hold denture adhesive cream per week and polident.The consumer also provided his emergency services (ems) report from (b)(6) 2016 as an email attachment.According to this report, the consumer reported catching something from a cat.According to the triage note, the consumer complained of increased cough, presyncope, twitching, heat in neck, intermittent weakness in right arm, and vomiting with emesis twice.He was diagnosed with numbness.Blood work revealed low phosphate and elevated creatinine (see lab values section for details).500 mg of oral phosphate was ordered for the consumer.Upon discharge, the consumer was advised to follow up with his family doctor in 7 days for phosphate level and kidney function.The consumer was also referred to a clinic.Consumer revealed that he was diagnosed with glaucoma 14 years ago and lost [vision in his] left eye and was told it was a matter of time before he lost sight in his right eye.When he first learned that he was losing sight and had his driver's license taken away, he felt that he lost all independence, all ability to go out, to socialize, to work, to function at all.The consumer became part of an organization that taught him how to cook again, he was able to look after his 90 year old father, they taught him how to label food, label clothes to match, taught him braille, and how to use a computer which is something he'd never done.He would not be working and travelling if not for this organization.Prior to joining he had a low quality of life, now he loves his life and wouldn't trade it with anyone he meets.In a referral request to the clinic mentioned above by the consumer's ophthalmologist.According to the referral form, the consumer's field of vision is less than 20 degrees diameter in both eyes.His right eye vision is 20/60.The ophthalmologist attributes vision loss in the right and left eyes to glaucoma and stroke.The ophthalmologist indicates that from his understanding, the consumer has had strokes in the past year which have further worsened his mobility status.The report also states that due to the consumer's lack of vision and balance, he often falls.He gets easily disoriented and gets lost.Follow-up information received via phone call on 31-jan-2017: consumer called to confirm that cancer, strokes, heart attacks, and any other adverse event issues happened prior to the use of poligrip strong hold denture adhesive cream and polident.The consumer indicated that nothing is wrong with the product except the expensive retails price.Additional follow-up received from consumer via phone call on 02-feb-2017: consumer was called back in regards to the last trip to the hospital in (b)(6) 2016 related to "another stroke" and "kidneys shutting down." consumer confirmed that he uses poligrip strong hold denture adhesive cream and polident on a daily basis for almost 3 to 4 years.The consumer also stated that he does not have the knowledge to make the connection between the stroke and kidneys shutting down in (b)(6) 2016 to the use of the products.Follow-up information received on 08 february 2017: this case is associated with a product quality complaint.No sample was received and no lot number given.No complaints had been received for any of the polident variants pertaining to causing a stroke for the consumer.The results were unable to determine why the product caused the consumer to have a stroke.The complaint was unsubstantiated.

Manufacturer Narrative

Report 1020379-2017-00020 is associated with argus case ca2017gsk016195, polident (unknown).Qa results: no sample received and no lot number given.No complaints have been received for any of the polident variants pertaining to causing a stroke for the consumer.The product is not to be ingested nor is the solution to be used as a mouthwash.The product is safe to use when used as directed on the package instructions.The complaint was unsubstantiated.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of stroke in a (b)(6) male patient who received double salt dental adhesive cream (poligrip strong hold denture adhesive cream) cream for denture wearer.Co-suspect products included polident (polident (unknown)) unknown for drug use for unknown indication.The patient's past medical history included cancer (cancer survivor), heart attack, stroke and impaired quality of life.Concurrent medical conditions included paralysis, blind, denture wearer, glaucoma (diagnosed 14 years ago), retinal detachment (left eye), cough, mobility decreased, drug allergy and pollen allergy.On an unknown date, the patient started poligrip strong hold denture adhesive cream and polident (unknown).On (b)(6) 2016, an unknown time after starting poligrip strong hold denture adhesive cream and polident (unknown), the patient experienced stroke (serious criteria hospitalization and gsk medically significant), cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting and numbness.In (b)(6) 2016, the patient experienced renal disorder (serious criteria gsk medically significant).On an unknown date, the patient experienced loss of vision (serious criteria gsk medically significant), mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased.The patient was treated with phosphate.On an unknown date, the outcome of the stroke, renal disorder, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness and mobility decreased were not reported and the outcome of the loss of vision, balance disorder, fall, disorientation, phosphate decreased and creatinine increased were unknown.It was unknown if the reporter considered the stroke, renal disorder, loss of vision, cough increased, presyncope, twitching, feeling hot, weakness of arms, vomiting, numbness, mobility decreased, balance disorder, fall, disorientation, phosphate decreased and creatinine increased to be related to poligrip strong hold denture adhesive cream and polident (unknown).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: in (b)(6) 2016 he was "again ambulanced to hospital with another stroke and learned that [his] kidneys are shutting down." the consumer indicated that a few years ago he had to have his top teeth removed and dentures to replace them.He has been using a full large tube of poligrip strong hold denture adhesive cream per week.The consumer has now been told that his bottom teeth are all being removed over the next 10 days, meaning that will be two tubes of poligrip strong hold denture adhesive cream per week and polident.The consumer also provided his emergency services (ems) report from (b)(6) 2016 as an email attachment.According to this report, the consumer reported catching something from a cat.According to the triage note, the consumer complained of increased cough, presyncope, twitching, heat in neck, intermittent weakness in right arm, and vomiting with emesis twice.He was diagnosed with numbness.Blood work revealed low phosphate and elevated creatinine (see lab values section for details).500mg of oral phosphate was ordered for the consumer.Upon discharge, the consumer was advised to follow up with his family doctor in 7 days for phosphate level and kidney function.The consumer was also referred to a clinic.Consumer revealed that he was diagnosed with glaucoma 14 years ago and lost [vision in his] left eye and was told it was a matter of time before he lost sight in his right eye.When he first learned that he was losing sight and had his driver's license taken away, he felt that he lost all independence, all ability to go out, to socialize, to work, to function at all.The consumer became part of an organization that taught him how to cook again, he was able to look after his 90 year old father, they taught him how to label food, label clothes to match, taught him braile, and how to use a computer which is something he'd never done.He would not be working and travelling if not for this organization.Prior to joining he had a low quality of life, now he loves his life and wouldn't trade it with anyone he meets.In a referral request to the clinic mentioned above by the consumer's ophthalmologist.According to the referral form, the consumer's field of vision is less than 20 degrees diameter in both eyes.His right eye vision is 20/60.The ophthalmologist attributes vision loss in the right and left eyes to glaucoma and stroke.The ophthalmologist indicates that from his understanding, the consumer has had strokes in the past year which have further worsened his mobility status.The report also states that due to the consumer's lack of vision and balance, he often falls.He gets easily disoriented and gets lost.Follow-up information received via phone call on (b)(6) 2017: consumer called to confirm that cancer, strokes, heart attacks, and any other adverse event issues happened prior to the use of poligrip strong hold denture adhesive cream and polident.The consumer indicated that nothing is wrong with the product except the expensive retails price.Additional follow-up received from consumer via phone call on (b)(6) 2017: consumer was called back in regards to the last trip to the hospital in december 2016 related to "another stroke" and "kidneys shutting down." consumer confirmed that he uses poligrip strong hold denture adhesive cream and polident on a daily basis for almost 3 to 4 years.The consumer also stated that he does not have the knowledge to make the connection between the stroke and kidneys shutting down in (b)(6) 2016 to the use of the products.Follow-up information received on 08 february 2017: no sample was received and no lot number given.No complaints had been received for any of the polident variants pertaining to causing a stroke for the consumer.The results were unable to determine why the product caused the consumer to have a stroke.The complaint was unsubstantiated.Final qa report received on 15 february 2017: final report received from qa for poligrip strong hold denture adhesive cream.This complaint was deemed unsubstantiated.

• Brand Name: POLIDENT (UNKNOWN)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• Manufacturer (Section G): GSK
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 6322817
• MDR Text Key: 67155750
• Report Number: 1020379-2017-00020
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 02/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR