MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER TABLETS

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Adhesive flow out and swallowed all [accidental device ingestion]; adhesive flow out and very hard to clean, it made the tongue and gum very uncomfortable, could not clear it completely [oral discomfort].Used more than 1 time per day [device used for unapproved schedule].Used half a tablet of cleanser tablet/ adhesive flow out [wrong technique in device usage process].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 double salt dental adhesive cream (polident denture adhesive cream fresh mint) cream for product used for unknown indication.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (polident denture adhesive max comfort) cream for product used for unknown indication, double salt dental adhesive cream (polident denture adhesive, flavor free) cream for product used for unknown indication and denture cleanser (polident denture cleanser tablets) tablet for product used for unknown indication.On an unknown date, the patient started polident denture adhesive cream fresh mint, polident denture adhesive max comfort, polident denture adhesive, flavor free and polident denture cleanser tablets.On an unknown date, an unknown time after starting polident denture adhesive cream fresh mint, polident denture adhesive max comfort, polident denture adhesive, flavor free and polident denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant), oral discomfort, device used for unapproved schedule, wrong technique in device usage process and product complaint.The action taken with polident denture adhesive cream fresh mint was unknown.The action taken with polident denture adhesive max comfort was unknown.The action taken with polident denture adhesive, flavor free was unknown.The action taken with polident denture cleanser tablets was unknown.On an unknown date, the outcome of the accidental device ingestion, oral discomfort, device used for unapproved schedule, wrong technique in device usage process and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, oral discomfort, device used for unapproved schedule and wrong technique in device usage process to be related to polident denture adhesive cream fresh mint, polident denture adhesive max comfort and polident denture adhesive, flavor free.It was unknown if the reporter considered the wrong technique in device usage process to be related to polident denture cleanser tablets.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: patient called to feedback my experience from after using your new products, hope your company could improve on it, or the sales of this product won't be good, didn't any consumer call to feedback about it patient might given up on using your product and change to another brand.She had been using your product with pink and white cream, she could accept the old version of adhesive cream, it could last about half day time when using, she waited more than half an hour in order to eat and drink after adhering.Used adhesive cream and when denture fell off, saw that all adhesive cream was gone, she would wash it clean and use adhesive cream again.She had swallowed plenty of adhesive cream for the way she used it, don't know if it would cause gastrointestinal problem!! the dent of lower denture was very small, she cleaned the denture, then squeezed the adhesive and spread out the adhesive cream, also did rinse mouth before wearing it.The old variants still could stick, but could not eat hard food, had to eat soft food or turn food into liquid form to take, which she could accept it.But the adhesive cream would flow out and need to clean it, this (old variant) was easy to clean and was acceptable.Follow up information was received on 10 aug 2020 from quality assurance (qa) department regarding complaint ((b)(4)) for unknown lot number.Follow up information dated (b)(6) 2020 were processed together.Summary and conclusion: the denture adhesive creams were specially formulated to form a tight seal and provide a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provided the adhesive strength that helped hold dentures in place.Gsk denture adhesives had showed to be effective in providing 12 hours hold across multiple randomized clinical trials.A batch documentation review was also performed to verify that there were no issues during the manufacture or packaging of the batch.Each investigation verified that the concentration of active material was within specification and that the product had been manufactured appropriately and complied with all required quality standards.The concentration of active ingredient in the lot/product in question was within specification and met all requirements of the release specification.All of the documentation pertinent to a specific lot of finished product is contained in a batch envelope.Prior to the disposition of the product, the contents of each batch envelope was reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verified that all test results meet specification requirements.As with any product, it was expected that the consumer may have different experiences based on various individual factors like the fit of the denture and the oral anatomy of the denture wearer, that may determine the performance of the denture adhesive.Quality assurance analysis revealed the complaint to be unsubstantiated.Follow up information was received on 10 aug 2020 from quality assurance (qa) department regarding complaint ((b)(4)) for unknown lot number.Summary and conclusion: denture adhesive creams were specially formulated to form a tight seal and provide a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provided the adhesive strength that helped hold dentures in place.Gsk denture adhesives had shown to be effective in providing 12 hours hold across multiple randomized clinical trials.The concentration of active ingredient in the lot/product in question was within specification and met all requirements of the release specification.All of the documentation pertinent to a specific lot of finished product was contained in a batch envelope.Prior to the disposition of the product, the contents of each batch envelope was reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verified that all test results meet specification requirements.As with any product, it was expected that the consumer may have different experiences based on various individual factors like the fit of the denture and the oral anatomy of the denture wearer, that may determine the performance of the denture adhesive.Quality assurance analysis revealed the complaint to be unsubstantiated.Follow up information was received on 14 aug 20 from quality assurance (qa) department regarding complaint ((b)(4)) for unknown lot number.Summary and conclusion: no sample was returned for this complaint and the lot/batch details were not received so a full investigation cannot be completed.As this information was not available the complaint cannot be substantiated and will be closed as inconclusive.No sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information was not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a batch envelope.Prior to the disposition of the product, the contents of each batch envelope was reviewed and approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verified that all test results meet specification requirements.Quality assurance analysis revealed the complaint to be inconclusive.Follow up information was received on 16 sep 2020 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference).Suspect product: polident max comfort denture adhesive cream 70g.The adhesive strength was tested on each bulk batch before filling.Adhesion strength was within specifications for all batches.According to etols many years of experience in manufacturing of adhesive creams, it was known that adhesion depends on several aspects of the individual customer, like eating behavior condition of the jaw (prosthesis, ph of saliva).Therefore, the complaint was considered as unsubstantiated.Quality assurance analysis revealed the complaint to be unsubstantiated.Follow up information was received on 17 sep 2020 from quality assurance (qa) department regarding complaint ((b)(4)) (complaint reference).Quality assurance analysis revealed the complaint to be unsubstantiated.

• Brand Name: POLIDENT DENTURE CLEANSER TABLETS
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 10655278
• MDR Text Key: 216568397
• Report Number: 1020379-2020-00041
• 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
• Report Date: 08/10/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2020
• Initial Date FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other