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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Complete Heart Block (2627)

Event Type  Injury  

Manufacturer Narrative

Mfr report is associated with argus case (b)(4), polident denture cleanser.

Event Description

Heart disease [heart disease, unspecified].Blocked blood vessel [heart block].Case description: this case was reported by a consumer via call center representative and described the occurrence of heart disease, unspecified in a (b)(6) female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for drug use for unknown indication.Co-suspect products included denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.Concomitant products included unknown pill after angioplasty.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disease, unspecified (serious criteria clinically significant/intervention required), heart block (serious criteria clinically significant/intervention required), wrong technique in drug usage process and once daily dose taken more frequently.Polident denture adhesive cream was discontinued (dechallenge was unknown).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the heart disease, unspecified, heart block, wrong technique in drug usage process and once daily dose taken more frequently were unknown.The reporter considered the heart disease, unspecified and heart block to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disease, unspecified and heart block to be related to polident denture cleanser.Additional details: concomitant products included unknown pill after angioplasty.The consumer wore denture for many years and had to use adhesive cream as it was removable.She stored polident denture adhesive cream near a sink.She used the product every day.In every morning, she brushed her teeth, used polident denture cleanser to clean her denture and then apply polident denture adhesive cream.The last time she used polident denture adhesive cream with broken tube was about last month.She stopped using it as the cream was hard.She burned the hardened cream and then used it (inappropriate use of product.Unintentional).She has done that for a few days.She used the product once in the morning.When she drank too much water or the denture became loose at night, she would use the product again (inappropriate dosing frequency.According to the label, consumer should use the product once daily.The intention is unknown).She already used a new tube for 2 weeks.She said she must eat hot thing because she experienced diarrhea when she ate something cold.She has undergone angioplasty for several times.But she did not think it was related to polident denture adhesive cream.This is because she ate something greasy which led to blocked blood vessel and heart disease.After she underwent angioplasty, she needed to take unknown pills and have follow up consultation regularly as instructed by her treating physician.

Event Description

This case was reported by a consumer via call center representative and described the occurrence of heart disease, unspecified in a 6-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for drug use for unknown indication.Co-suspect products included denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.Concomitant products included unknown pill after angioplasty.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disease, unspecified (serious criteria clinically significant/intervention required), heart block (serious criteria clinically significant/intervention required), wrong technique in drug usage process and once daily dose taken more frequently.Polident denture adhesive cream was discontinued (dechallenge was unknown).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the heart disease, unspecified, heart block, wrong technique in drug usage process and once daily dose taken more frequently were unknown.The reporter considered the heart disease, unspecified and heart block to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disease, unspecified and heart block to be related to polident denture cleanser.Additional details: concomitant products included unknown pill after angioplasty.The consumer wore denture for many years and had to use adhesive cream as it was removable.She stored polident denture adhesive cream near a sink.She used the product every day.In every morning, she brushed her teeth, used polident denture cleanser to clean her denture and then apply polident denture adhesive cream.The last time she used polident denture adhesive cream with broken tube was about last month.She stopped using it as the cream was hard.She burned the hardened cream and then used it (inappropriate use of product.Unintentional).She has done that for a few days.She used the product once in the morning.When she drank too much water or the denture became loose at night, she would use the product again (inappropriate dosing frequency.According to the label, consumer should use the product once daily.The intention is unknown).She already used a new tube for 2 weeks.She said she must eat hot thing because she experienced diarrhea when she ate something cold.She has undergone angioplasty for several times.But she did not think it was related to polident denture adhesive cream.This is because she ate something greasy which led to blocked blood vessel and heart disease.After she underwent angioplasty, she needed to take unknown pills and have follow up consultation regularly as instructed by her treating physician.Follow up information was received from quality assurance department received on 07 jan 2019: quality assurance (qa) department analysis revealed the complaint to be unsubstantiated.This case was associated with a product complaint.Current condition included angioplasty.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disorder (serious criteria clinically significant/intervention required) and product complaint.On an unknown date, the outcome of the heart disorder and product complaint were unknown.The reporter considered the heart disorder to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disorder to be related to polident denture cleanser.Follow up information was received on 23 jan 2019: this case was reported by a consumer and described the occurrence of heart disorder in a 6-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number gm2d, expiry date september 2019) for drug use for unknown indication.The quality assurance team received the compliant sample and provided the batch number and expiry date.Follow up information was received from quality assurance department received on 21 feb 2019: quality assurance (qa) department analysis revealed the complaint to be unsubstantiated.Expiry date was updated as 01 sep 2019.Follow up information was received from quality assurance department received on 27 feb 2019: quality assurance (qa) department analysis revealed the complaint to be substantiated.No sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.Updated on 21 feb 2019.The complaint sample was sent to the lab for analysis, see results below: test: description specification: a reddish pink mass of gums and petrolatum, free of lumps, granular particles or foreign matter result: complaint sample: contains hard lump, retain sample: complies test: ph specification: 6.5 to 7.5 result: retain sample: 6.8 test: extrudability specification: easy to moderate result: complaint sample: contains hard lump, sample cannot be dispensed, does not comply.Retain sample: moderate, complies.Test: separation specification: none to slight result: retain sample: very slight, complies.Conclusion: testing was carried out on the complaint sample and the results for description and extrudability did not meet specification requirements due to the solidified product inside the tube, this type of complaint was believed to be related to the consumer exposing the fixative cream to moisture.When the product was exposed to moisture and dried, it became a hardened material.The results for the retain sample met specification requirements indicating that the product was manufactured appropriately and complied with the required quality standards.Tubes were made from plastic laminates; layers of thin materials stuck together to make a web.One type of laminate (abl) had a layer of aluminum, designed to obstruct migration of products and gases through the laminate.A sheet of laminate was formed into a tube and welded into place.This weld was known as the side-seam.The complaints received for the reason code cpa seam br relating to side seam failures were expected / common customer complaints.The failure modes related to side seam failures are: 1.De-lamination of the web between the plastic and aluminum layers.This failure mode had been believed to be caused by product laminated interaction & not process related.Examination of customer complaints returned had shown that this was the largest contributor to side seam failure.2.Key.The tube was damaged by a mechanical squeezing device.Not process related.3.Burst.Tubes displayed this defect showed no apparent weakness of the side seam, this type of failure might be caused by customer handling.Not process related.4.Butt weld.No side seam overlap formed, this might occurred following a line stoppage.Process related defect.5.Unzip/cold weld.These defects were due to poor welds which came apart.Process related defect.6.Tear.The laminate next to the side seam was easy to tear due to tensile strength loss.Process related defect.De lamination related defects: pira testing had been completed in relation to laminated and all failing samples had been analyzed.Process related defects: in summary the following process changes had been implemented at the tube manufacturing site: standardization (machine parts, machine operation, setting sheets and operator training).Addition of 5th generation tooling used on the tube body maker to minimize the chances of kinking during tube formation.Improved in process controls with side seam cross section.Process failure mode effect analysis.Seam height sensors & reject verification sensors installed.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), polident denture cleanser.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of heart disease, unspecified in a 6-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for drug use for unknown indication.Co-suspect products included denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.Concomitant products included unknown pill after angioplasty.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disease, unspecified (serious criteria clinically significant/intervention required), heart block (serious criteria clinically significant/intervention required), wrong technique in drug usage process and once daily dose taken more frequently.Polident denture adhesive cream was discontinued (dechallenge was unknown).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the heart disease, unspecified, heart block, wrong technique in drug usage process and once daily dose taken more frequently were unknown.The reporter considered the heart disease, unspecified and heart block to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disease, unspecified and heart block to be related to polident denture cleanser.Additional details: concomitant products included unknown pill after angioplasty.The consumer wore denture for many years and had to use adhesive cream as it was removable.She stored polident denture adhesive cream near a sink.She used the product every day.In every morning, she brushed her teeth, used polident denture cleanser to clean her denture and then apply polident denture adhesive cream.The last time she used polident denture adhesive cream with broken tube was about last month.She stopped using it as the cream was hard.She burned the hardened cream and then used it (inappropriate use of product.Unintentional).She has done that for a few days.She used the product once in the morning.When she drank too much water or the denture became loose at night, she would use the product again (inappropriate dosing frequency.According to the label, consumer should use the product once daily.The intention is unknown).She already used a new tube for 2 weeks.She said she must eat hot thing because she experienced diarrhea when she ate something cold.She has undergone angioplasty for several times.But she did not think it was related to polident denture adhesive cream.This is because she ate something greasy which led to blocked blood vessel and heart disease.After she underwent angioplasty, she needed to take unknown pills and have follow up consultation regularly as instructed by her treating physician.Follow up information was received from quality assurance department received on 07 jan 2019: quality assurance (qa) department analysis revealed the complaint to be unsubstantiated.This case was associated with a product complaint.Current condition included angioplasty.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disorder (serious criteria clinically significant/intervention required) and product complaint.On an unknown date, the outcome of the heart disorder and product complaint were unknown.The reporter considered the heart disorder to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disorder to be related to polident denture cleanser.Follow up information was received on 23 jan 2019: this case was reported by a consumer and described the occurrence of heart disorder in a 6-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number gm2d, expiry date september 2019) for drug use for unknown indication.The quality assurance team received the compliant sample and provided the batch number and expiry date.

Manufacturer Narrative

Initial report is associated with argus case (b)(4), polident denture cleanser.

Event Description

Heart disease.Blocked blood vessel [heart block].Case description: this case was reported by a consumer via call center representative and described the occurrence of heart disease, unspecified in a 6-decade-old female patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for drug use for unknown indication.Co-suspect products included denture cleanser (polident denture cleanser) tablet for drug use for unknown indication.Concomitant products included unknown pill after angioplasty.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disease, unspecified (serious criteria clinically significant/intervention required), heart block (serious criteria clinically significant/intervention required), wrong technique in drug usage process and once daily dose taken more frequently.Polident denture adhesive cream was discontinued (dechallenge was unknown).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the heart disease, unspecified, heart block, wrong technique in drug usage process and once daily dose taken more frequently were unknown.The reporter considered the heart disease, unspecified and heart block to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disease, unspecified and heart block to be related to polident denture cleanser.Additional details: concomitant products included unknown pill after angioplasty.The consumer wore denture for many years and had to use adhesive cream as it was removable.She stored polident denture adhesive cream near a sink.She used the product every day.In every morning, she brushed her teeth, used polident denture cleanser to clean her denture and then apply polident denture adhesive cream.The last time she used polident denture adhesive cream with broken tube was about last month.She stopped using it as the cream was hard.She burned the hardened cream and then used it (inappropriate use of product.Unintentional).She has done that for a few days.She used the product once in the morning.When she drank too much water or the denture became loose at night, she would use the product again (inappropriate dosing frequency.According to the label, consumer should use the product once daily.The intention is unknown).She already used a new tube for 2 weeks.She said she must eat hot thing because she experienced diarrhea when she ate something cold.She has undergone angioplasty for several times.But she did not think it was related to polident denture adhesive cream.This is because she ate something greasy which led to blocked blood vessel and heart disease.After she underwent angioplasty, she needed to take unknown pills and have follow up consultation regularly as instructed by her treating physician.Follow up information was received from quality assurance department received on 07 jan 2019: quality assurance (qa) department analysis revealed the complaint to be unsubstantiated.This case was associated with a product complaint.Current condition included angioplasty.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced heart disorder (serious criteria clinically significant/intervention required) and product complaint.On an unknown date, the outcome of the heart disorder and product complaint were unknown.The reporter considered the heart disorder to be unrelated to polident denture adhesive cream.It was unknown if the reporter considered the heart disorder to be related to polident denture cleanser.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 8213596
• MDR Text Key: 131964732
• Report Number: 1020379-2019-00001
• 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,Followup
• Report Date: 12/28/2018

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
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 12/28/2018; 01/23/2019; 02/21/2019
• Supplement Dates FDA Received: 01/29/2019; 02/01/2019; 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR