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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER
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BLOCK DRUG CO., INC. POLIDENT DENTURE CLEANSER Back to Search Results
Device Problem Product Quality Problem (1506)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
'mouthful of plague' [plague].Case description: this case was reported by a consumer via call center representative and described the occurrence of plague in a (b)(6) female patient who received double salt dental adhesive cream (polident denture adhesive max seal) cream (batch number ur9p, expiry date 30th november 2021) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (polident denture adhesive, flavor free) cream for denture wearer and denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive max seal at an unknown dose and frequency, polident denture adhesive, flavor free at an unknown dose and frequency and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced plague (serious criteria gsk medically significant), intentional misuse in dosing frequency and product complaint.The action taken with polident denture adhesive max seal was unknown.The action taken with polident denture adhesive, flavor free was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the plague was not reported and the outcome of the intentional misuse in dosing frequency and product complaint were unknown.It was unknown if the reporter considered the plague to be related to polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser.Additional details: the consumer had problem with the polident max seal.The consumer was using lot of it during the day as it was not holding the dentures.This tube lasts for a few days only.Every time consumer ate need to re-apply.The consumer had a mouthful of plague.The dentures were well fit and new.Some tubes are good and worked well but a lot did not work (didn't hold).It was recommended to me by my dental technician.The consumer had used polident cleanser too and that's not too bad.The consumer used the polident, non-flavoured one until i bought this one.The consumer had been using it for 2 years.The consumer started applying more than once a day when started using the max seal.The consumer read the label prior to using the product.The event mouthful of plague was not clearly mention so taken as reported.As per label of polident apply polident once a day to clean dry dentures.
 
Event Description
Case description: this case was reported by a consumer via call center representative and described the occurrence of plague in a 54-year-old female patient who received double salt dental adhesive cream (polident denture adhesive max seal) cream (batch number ur9p, expiry date (b)(6)2021) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (polident denture adhesive, flavor free) cream for denture wearer and denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive max seal at an unknown dose and frequency, polident denture adhesive, flavor free at an unknown dose and frequency and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced plague (serious criteria gsk medically significant), intentional misuse in dosing frequency and product complaint.The action taken with polident denture adhesive max seal was unknown.The action taken with polident denture adhesive, flavor free was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the plague was not reported and the outcome of the intentional misuse in dosing frequency and product complaint were unknown.It was unknown if the reporter considered the plague to be related to polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser.Additional details the consumer had problem with the polident max seal.The consumer was using lot of it during the day as it was not holding the dentures.This tube lasts for a few days only.Every time consumer ate need to re-apply.The consumer had a mouthful of plague.The dentures were well fit and new.Some tubes are good and worked well but a lot did not work (didn't hold).It was recommended to me by my dental technician.The consumer had used polident cleanser too and that's not too bad.The consumer used the polident, non-flavoured one until i bought this one.The consumer had been using it for 2 years.The consumer started applying more than once a day when started using the max seal.The consumer read the label prior to using the product.The event mouthful of plague was not clearly mention so taken as reported.As per label of polident apply polident once a day to clean dry dentures.Follow up information was received from consumer on (b)(6)2021.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced intentional device misuse.On an unknown date, the outcome of the intentional device misuse was unknown.It was unknown if the reporter considered the intentional device misuse to be related to polident denture.The reporter had stated that the one nearly empty tube of the complaint sample was returned.The complaint of do not hold has already been investigated.There was hardly any content left inside the tube, insufficient for any sort of investigation.Hence the nearly empty tube was discarded.Follow up information was received on 07 jun 2019: the patient started the product approximately 3 months ago.She was still using the same product as she purchased two tubes at once.Both had same batch number.The patient had gone back to using polident flavor free denture adhesive.She used on lower denture.After every time the patient ate or drank fluids, she used the product upto 10 times a day.Each time the patient ate something the denture would become loose and move around the lower mouth and food would go under the denture.Follow up information received with qa results on (b)(6)2019: the product did not hold the dentures.A product quality complaint was raised by consumer as the polident max seal 40 g was unable to hold the dentures for 12 hours.No sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.Qa analysis revealed the complaint to be unsubstantiated.The reports received on 07 jun 2019 and 19 jun 2019, were processed together.Follow up information was received from quality assurance department on (b)(6)2019: concurrent medical conditions included lactose intolerance and penicillin allergy.In 2019, the patient started polident denture adhesive max seal.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced intentional misuse in dosing frequency.On an unknown date, the outcome of the intentional misuse in dosing frequency was unknown.The quality assurance revealed the complaint to be unsubstantiated.No new information received on (b)(6)2019.This report is being resubmitted to capture corrections.The information was received on (b)(6)2019 and is as follows: follow up 3 gsk receipt date was corrected from (b)(6)2019 to (b)(6)2019.
 
Manufacturer Narrative
Mfr report # 1020379-2019-00033 is associated with case (b)(4).
 
Manufacturer Narrative
Argus case (b)(4).
 
Event Description
'mouthful of plague' [plague].Use at greater than recommended frequency [intentional device misuse].Case description: this case was reported by a consumer via call center representative and described the occurrence of plague in a 54-year-old female patient who received double salt dental adhesive cream (polident denture adhesive max seal) cream (batch number ur9p, expiry date 30th november 2021) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (polident denture adhesive, flavor free) cream for denture wearer and denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive max seal at an unknown dose and frequency, polident denture adhesive, flavor free at an unknown dose and frequency and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced plague (serious criteria gsk medically significant), intentional misuse in dosing frequency and product complaint.The action taken with polident denture adhesive max seal was unknown.The action taken with polident denture adhesive, flavor free was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the plague was not reported and the outcome of the intentional misuse in dosing frequency and product complaint were unknown.It was unknown if the reporter considered the plague to be related to polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser.Additional details: the consumer had problem with the polident max seal.The consumer was using lot of it during the day as it was not holding the dentures.This tube lasts for a few days only.Every time consumer ate need to re-apply.The consumer had a mouthful of plague.The dentures were well fit and new.Some tubes are good and worked well but a lot did not work (didn't hold).It was recommended to me by my dental technician.The consumer had used polident cleanser too and that's not too bad.The consumer used the polident, non-flavoured one until i bought this one.The consumer had been using it for 2 years.The consumer started applying more than once a day when started using the max seal.The consumer read the label prior to using the product.The event mouthful of plague was not clearly mention so taken as reported.As per label of polident apply polident once a day to clean dry dentures.Follow up information was received from consumer on 12 jun 2019.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced intentional device misuse.On an unknown date, the outcome of the intentional device misuse was unknown.It was unknown if the reporter considered the intentional device misuse to be related to polident denture.The reporter had stated that the one nearly empty tube of the complaint sample was returned.The complaint of do not hold has already been investigated.There was hardly any content left inside the tube, insufficient for any sort of investigation.Hence the nearly empty tube was discarded.
 
Event Description
Mouthful of plague [plague].Case description: this case was reported by a consumer via call center representative and described the occurrence of plague in a 54-year-old female patient who received double salt dental adhesive cream (polident denture adhesive max seal) cream (batch number ur9p, expiry date 30th november 2021) for denture wearer.This case was associated with a product complaint.Co-suspect products included double salt dental adhesive cream (polident denture adhesive, flavor free) cream for denture wearer and denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive max seal at an unknown dose and frequency, polident denture adhesive, flavor free at an unknown dose and frequency and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced plague (serious criteria gsk medically significant), intentional misuse in dosing frequency and product complaint.The action taken with polident denture adhesive max seal was unknown.The action taken with polident denture adhesive, flavor free was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the plague was not reported and the outcome of the intentional misuse in dosing frequency and product complaint were unknown.It was unknown if the reporter considered the plague to be related to polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser.Additional details: the consumer had problem with the polident max seal.The consumer was using lot of it during the day as it was not holding the dentures.This tube lasts for a few days only.Every time consumer ate need to re-apply.The consumer had a mouthful of plaque.The dentures were well fit and new.Some tubes are good and worked well but a lot did not work (didn't hold).It was recommended to me by my dental technician.The consumer had used polident cleanser too and that's not too bad.The consumer used the polident, non-flavoured one until i bought this one.The consumer had been using it for 2 years.The consumer started applying more than once a day when started using the max seal.The consumer read the label prior to using the product.The event mouthful of plague was not clearly mention so taken as reported.As per label of polident apply polident once a day to clean dry dentures.Follow up information was received from consumer on 12 jun 2019.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced intentional device misuse.On an unknown date, the outcome of the intentional device misuse was unknown.It was unknown if the reporter considered the intentional device misuse to be related to polident denture.The reporter had stated that the one nearly empty tube of the complaint sample was returned.The complaint of do not hold has already been investigated.There was hardly any content left inside the tube, insufficient for any sort of investigation.Hence the nearly empty tube was discarded.Follow up information was received on 07 jun 2019: the patient started the product approximately 3 months ago.She was still using the same product as she purchased two tubes at once.Both had same batch number.The patient had gone back to using polident flavor free denture adhesive.She used on lower denture.After every time the patient ate or drank fluids, she used the product upto 10 times a day.Each time the patient ate something the denture would become loose and move around the lower mouth and food would go under the denture.Follow up information received with qa results on 19 jun 2019: the product did not hold the dentures.A product quality complaint was raised by consumer as the polident max seal 40 g was unable to hold the dentures for 12 hours.No sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.Qa analysis revealed the complaint to be unsubstantiated.The reports received on 07 jun 2019 and 19 jun 2019, were processed together.Follow up information was received from quality assurance department on 27 jun 2019: concurrent medical conditions included lactose intolerance and penicillin allergy.In 2019, the patient started polident denture adhesive max seal.On an unknown date, an unknown time after starting polident denture adhesive max seal, polident denture adhesive, flavor free and polident denture cleanser, the patient experienced intentional misuse in dosing frequency.On an unknown date, the outcome of the intentional misuse in dosing frequency was unknown.The quality assurance revealed the complaint to be unsubstantiated.
 
Manufacturer Narrative
Product problem is only associated with polident max seal and not polident denture cleanser.Argus case: (b)(4).
 
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Brand Name
POLIDENT DENTURE CLEANSER
Type of Device
DENTURE CLEANSER
Manufacturer (Section D)
BLOCK DRUG CO., INC.
memphis TN
MDR Report Key8688112
MDR Text Key147640322
Report Number1020379-2019-00033
Device Sequence Number1
Product Code EFT
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Type of Report Initial,Followup,Followup,Followup
Report Date 05/27/2019
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
Initial Date Manufacturer Received 05/27/2019
Initial Date FDA Received06/11/2019
Supplement Dates Manufacturer Received06/07/2019
06/27/2019
06/18/2019
Supplement Dates FDA Received06/19/2019
07/15/2019
09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age54 YR
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