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

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

When he uses the adhesive cream, it comes out to the side of the denture and melt, so it is swallowed [accidental device ingestion] he feels like a bit of phlegm is coming out these days.[phlegm] it is uncomfortable because the adhesive cream he bought is not detached [discomfort] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received double salt dental adhesive cream (polident denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.Co-suspect products included denture cleanser (polident denture cleanser) unknown (batch number unk, expiry date unknown) for denture wearer.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 accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), phlegm, discomfort and product complaint.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion, phlegm, discomfort and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, phlegm and discomfort to be related to polident denture adhesive cream and polident denture cleanser.Additional details: the adverse event was reported by a consumer via call center representative (phone) on 30sep2021.The consumer stated that "the product i bought from the market produces less foam than the samples.Adhesive cream: it was said that sample adhesive cream is better than the purchased adhesive cream when detaching the denture.It is uncomfortable because the adhesive cream he bought is not detached well when detaching the denture adhesive cream.When he uses the adhesive cream, it comes out to the side of the denture and melt, so it is swallowed and he feels like a bit of phlegm is coming out these days.Previously, a male consumer had used polident adhesive cream sample and cleanser sample which were received.It was said that the cleanser bought from the market produces less foam than the samples and the sample adhesive cream is better than sample adhesive cream when detaching the denture." follow up: qa investigational results follow up qa investigational results were received for product quality complaint (b)(4)), for polident denture adhesive unknown variant and size (batch no: unk) on 04oct2021.The evaluation results concluded the complaint to be unsubstantiated.Investigation evaluation: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is 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 is 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 verifies that all test results meet specification requirements.Should the complaint sample or lot details become available the case will be reopened.

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• MDR Report Key: 12656626
• MDR Text Key: 281084220
• Report Number: 3003721894-2021-00341
• Device Sequence Number: 1
• Product Code: KOT
• 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: 09/30/2021

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: 09/30/2021
• Initial Date FDA Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other