MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT FOR PARTIALS CLEAN + PROTECT; DENTURE CLEANSER

Lot Number MB261824H

Device Problems Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Choking (2464)

Event Type  Injury  

Manufacturer Narrative

This report is associated with (b)(4), polident for partials clean + protect.Qa results: qa results: all polident formulas are manufactured to produce a minty aroma.All polident products are consistently manufactured and packaged per a standard process to ensure the consistent manufacture of product meeting the packaged finished product specifications (pfps).There are manual in process quality checks performed throughout the entire process to ensure the consistent manufacture and packaging of product in accordance with product finished packaging specification (pfps).All lots are tested against pfps and reviewed prior to release as part of the routine batch disposition process.Polident tablets are specifically formulated to remove stains and control denture odors.The product should be used as instructed on the carton directions.Package instructions advise that he denture should be brushed with the solution using a soft brush to remove any buildup or film left on the denture and then rinse well.For best results, polident tablets should be used every day.When used as directed, the tablets will remove stains and plaque and also kill odor causing bacteria that brushing alone can miss.A review of internal records found no evidence of issues noted to have occurred during the packaging of the batch that would have contributed to the complaint issue reported.All sample evaluations performed throughout the packaging process were noted to have passed.All batch documentation and product release testing conformed to specifications, meeting specifications per the product finished packaging specification (pfps) prior to release disposition by the manufacturing site quality unit.No deviations that could be attributable to the subject complaint were identified to have occurred prior to lot release or associated with the lot post manufacturing site release.A retain evaluation was not performed for this product lot due to the subject of the complaint.No retain testing or evaluation is determined to be required when the reported complaint is a subjective characteristic of the product, for which all of the required ingredients were confirmed to be added in the correct amounts specified per the formulation.A complaint sample was not obtained from the consumer and forwarded to the manufacturing site for evaluation.Therefore, a complaint sample evaluation was not able to be performed as part of the investigation.Lot specific, complaint reason, and product family trending was reviewed.The lot specific complaint history query of the system data yielded no other additional complaint issues for the same reason reported throughout the shelf life of the product to the date of complaint evaluation.The most recent 24 month signal analysis (jun2016 through may2018) was reviewed for the product family and complaint reason subject to this complaint issue.No actionable trend was identified.The scope is limited to this complaint case and this packaging lot.There is no evidence of an actionable trend indicating the need to expand to other production lots.There is no indication of an adverse trend for the product lot or product family for the subject complaint type.The processes in place to ensure consistent manufacture of packaged finished product are robust with final finished product testing to ensure that product meets specification prior to release.Without evidence of a misformulation or actionable trend, this consumer complaint is considered subjective, influenced by method and frequency of use, and is therefore determined to be unsubstantiated.Based on the information available for this investigation, there is no risk to consumer safety, regulatory compliance, or product supply.

Event Description

It makes me choke [choking].It leaves a thick almost like mucus but white and its all over my teeth, my gums, and my throat [white film in mouth].It leaves a thick almost like mucus but white and its all over my teeth, my gums, and my throat.It makes me choke [oropharyngeal discomfort].Use for dental cleaning [device use in unapproved indication].Case description: this case was reported by a consumer and described the occurrence of choking in a (b)(6) female patient who received denture cleanser (polident for partials clean + protect) tablet (batch number mb261824h, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On an unknown date, the patient started polident for partials clean + protect at an unknown dose and frequency.On an unknown date, an unknown time after starting polident for partials clean + protect, the patient experienced choking (serious criteria gsk medically significant), white film in mouth, oropharyngeal discomfort, device use in unapproved indication and product complaint.Polident for partials clean + protect was discontinued (dechallenge was positive).On an unknown date, the outcome of the choking, white film in mouth and oropharyngeal discomfort were recovering/resolving and the outcome of the device use in unapproved indication and product complaint were unknown.The reporter considered the choking and white film in mouth to be related to polident for partials clean + protect.It was unknown if the reporter considered the oropharyngeal discomfort and device use in unapproved indication to be related to polident for partials clean + protect.Additional details, adverse event information was received on 07 june 2018.Consumer reported that "i bought the partials by mistake and i got 2 of them and the thing of it is, it leaves a thick almost like mucus but white and its all over my teeth, my gums, and my throat.It makes me choke.I cant get rid of it.Is there any way i can give this one back and get the other one that i love so much? i love the 3 minute, because if i go to take a shower i put them in for 3 minutes and they feel refreshed.The overnight keeps my teeth clean from the plaque".Follow-up information was received on 11 june 2018 from the quality assurance (qa) department regarding complaint (b)(4) and lot number mb261824h.The investigation report concluded that, there is no indication of an adverse trend for the product lot or product family for the subject complaint type.The processes in place to ensure consistent manufacture of packaged finished product are robust with final finished product testing to ensure that product meets specification prior to release.Without evidence of a misformulation or actionable trend, this consumer complaint is considered subjective, influenced by method and frequency of use, and is therefore determined to be unsubstantiated.Initial and follow-up information was processed together.

Manufacturer Narrative

Argus case: (b)(4), polident for partials clean + protect.Follow up information received from gms/qa product quality investigation received 16 july 2018: a complaint sample was obtained from the consumer and forwarded to the gsk memphis site for evaluation.The sample received was comprised of the display carton for the subject lot, and 6 full sheets of 4, and 2 partial sheets totaling 5 tablets.All tablets were found to be individually sealed with no evidence of seal defects, perforation line defects, or nonconformity packaged finished product specifications (pfps).One randomly selected individual tablet pouch was opened to verify effervescence, foam head, color and a subjective observation of the scent of the solution.Per the package directions, the tablet was placed into water and was observed to disentigrate, produce effervescence, resulting in a foam head, a blue solution, (subjectively observed) a minty aroma.Qualitatively, there were no notable observations that subjectively indicated an abnormality in the tablet disentigration and production of a solution with the effervesence, foaming, and scent characteristics.Lot specific, complaint reason, and product family trending was reviewed.The lot specific complaint history query of the crs system data yielded no other additional complaint issues for the same reason reported throughout the shelf life of the product to the date of complaint evaluation.The most recent 24 month signal analysis (jul2016 through jun2018) was reviewed for the product family and complaint reason subject to this complaint issue.No actionable trend was identified.The scope is limited to this complaint case and this packaging lot.There is no evidence of an actionable trend indicating the need to expand to other production lots.There is no indication of an adverse trend for the product lot or product family for the subject complaint type.The processes in place to ensure consistent manufacture of packaged finished product are robust with final finished product testing to ensure that product meets specification prior to release.Without evidence of a misformulation or actionable trend, this consumer complaint is considered subjective, influenced by method and frequency of use, and is therefore determined to be unsubstantiated.This consumer complaint is determined to subjective, influenced by water quality, method and frequency of use.As such, this consumer complaint is unsubstantiated.

Event Description

Case description: this case was reported by a consumer and described the occurrence of choking in a 84-year-old female patient who received denture cleanser (polident for partials clean + protect) tablet (batch number: mb261824h, expiry date unknown) for dental cleaning.This case was associated with a product complaint.On an unknown date, the patient started polident for partials clean + protect at an unknown dose and frequency.On an unknown date, an unknown time after starting polident for partials clean + protect, the patient experienced choking (serious criteria gsk medically significant), white film in mouth, oropharyngeal discomfort, device use in unapproved indication and product complaint.Polident for partials clean + protect was discontinued (dechallenge was positive).On an unknown date, the outcome of the choking, white film in mouth and oropharyngeal discomfort were recovering/resolving and the outcome of the device use in unapproved indication and product complaint were unknown.The reporter considered the choking and white film in mouth to be related to polident for partials clean + protect.It was unknown if the reporter considered the oropharyngeal discomfort and device use in unapproved indication to be related to polident for partials clean + protect.Additional details: adverse event information was received on (b)(6) 2018.Consumer reported that "i bought the partials by mistake and i got 2 of them and the thing of it is, it leaves a thick almost like mucus but white and its all over my teeth, my gums, and my throat.It makes me choke.I cant get rid of it.Is there any way i can give this one back and get the other one that i love so much? i love the 3 minute, because if i go to take a shower i put them in for 3 minutes and they feel refreshed.The overnight keeps my teeth clean from the plaque".Follow-up information was received on 11 june 2018 from the quality assurance (qa) department regarding complaint number: (b)(4) and lot number: mb261824h.The investigation report concluded that, there is no indication of an adverse trend for the product lot or product family for the subject complaint type.The processes in place to ensure consistent manufacture of packaged finished product are robust with final finished product testing to ensure that product meets specification prior to release.Without evidence of a misformulation or actionable trend, this consumer complaint is considered subjective, influenced by method and frequency of use, and is therefore determined to be unsubstantiated.Initial and follow-up information was processed together.Follow-up information was received on 25 june 2018.Product sample polident for partials was received.Lot: mb261824h.Follow-up information was received on 16 july 2018 from the quality assurance (qa) department regarding complaint number: (b)(4) and lot number: mb261824h.The investigation report concluded that, without evidence of a misformulation or actionable trend this consumer complaint was determined to subjective, influenced by water quality, method and frequency of use.As such, this consumer complaint was closed as unsubstantiated.

• Brand Name: POLIDENT FOR PARTIALS CLEAN + PROTECT
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; 2149 harbor avenue; memphis TN 38113
• MDR Report Key: 7606121
• MDR Text Key: 111223603
• Report Number: 1020379-2018-00025
• 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
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: MB261824H
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2018
• Initial Date FDA Received: 06/15/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR