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

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

After the consumer used the polident denture adhesive cream and cleaned it up for about an hour, the consumer felt as if there was still some melted adhesive cream in his throat./ ver hard [foreign body in throat].Likely to cause nausea (polident denture adhesive cream ) [nausea].Discomfort (polident denture cleanser) [discomfort].Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a (b)(6) year-old male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.This case was associated with a product complaint.Co-suspect products included denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced foreign body in throat (serious criteria gsk medically significant), nausea, discomfort, wrong technique in product usage process, product cleaning inadequate and product complaint.The action taken with polident denture adhesive cream was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the foreign body in throat, nausea, discomfort, wrong technique in product usage process, product cleaning inadequate and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, nausea and discomfort to be related to polident denture adhesive cream and polident denture cleanser.Additional details: consumer stated that previous polident denture adhesive clean he had used made a sizzling sound when put in water and generate bubbles at once, but the one he had used recently would not make a sizzling sound and bubbles generated were less and slow.The consumer also stated that he found a problem when he had used the first tablet to soak his dentures and the consumer had to change if for another one, which was fine.But after a few days, the problem occurred again.The consumer used tap water to soak the polident denture cleanser.The consumer had full upper and lower denture.The consumer uses polident denture cleanser every night.Agent aked the customer if he had suffered from any discomfort after using polident denture cleanser, the consumer said he had discomfort when he had started using it.After removing the dentures consumer would brush with toothbrush.The consumer had cleaned his denturesthroughly.But after few hours the consumer felt as there was some melted adhesive cream in the throat after using polident denture adhesive cream.The consumer had been using polident denture adhesive cream.For 10 years.The consumer found the problem in last and year so.The consumer stated that he could remove the melted denture adhevie from the throat but it was very hard and likely to cause nausea.

Manufacturer Narrative

Argus case (b)(4).

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of foreign body in throat in a 60-year-old male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream for denture wearer.This case was associated with a product complaint.Co-suspect products included denture cleanser (polident denture cleanser) tablet for denture wearer.On an unknown date, the patient started polident denture adhesive cream and polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture adhesive cream and polident denture cleanser, the patient experienced foreign body in throat (serious criteria gsk medically significant), nausea, discomfort, wrong technique in product usage process, product cleaning inadequate and product complaint.The action taken with polident denture adhesive cream was unknown.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the foreign body in throat, nausea, discomfort, wrong technique in product usage process, product cleaning inadequate and product complaint were unknown.It was unknown if the reporter considered the foreign body in throat, nausea and discomfort to be related to polident denture adhesive cream and polident denture cleanser.Additional details: consumer stated that previous polident denture adhesive clean he had used made a sizzling sound when put in water and generate bubbles at once, but the one he had used recently would not make a sizzling sound and bubbles generated were less and slow.The consumer also stated that he found a problem when he had used the first tablet to soak his dentures and the consumer had to change if for another one, which was fine.But after a few days, the problem occurred again.The consumer used tap water to soak the polident denture cleanser.The consumer had full upper and lower denture.The consumer uses polident denture cleanser every night.Agent asked the customer if he had suffered from any discomfort after using polident denture cleanser, the consumer said he had discomfort when he had started using it.After removing the dentures consumer would brush with toothbrush.The consumer had cleaned his dentures throughly.But after few hours the consumer felt as there was some melted adhesive cream in the throat after using polident denture adhesive cream.The consumer had been using polident denture adhesive cream.For 10 years.The consumer found the problem in last and year so.The consumer stated that he could remove the melted denture adhesive from the throat but it was very hard and likely to cause nausea.Follow up information received via consumer on 08 jun 2020: patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.Polident denture cleanser was continued with no change.On an unknown date, the outcome of the foreign body in throat, nausea and discomfort were not recovered/not resolved and the outcome of the wrong technique in product usage process, product cleaning inadequate and product complaint were unknown.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.The case was corrected on 08 jun 2020 changes were made in med watch form as additional information was received in the follow up.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis, tn
• MDR Report Key: 10118478
• MDR Text Key: 195580062
• Report Number: 1020379-2020-00032
• 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
• Report Date: 05/28/2020

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR