MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009; DENTURE CLEANSER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dementia (4405)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Dementia [dementia aggravated].Case description: this case was reported by a consumer via call center representative and described the occurrence of dementia aggravated in a elderly male patient who received denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for denture wearer.Concurrent medical conditions included denture wearer and dementia.On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On an unknown date, an unknown time after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced dementia aggravated (serious criteria gsk medically significant), wrong technique in product usage process and accidental ingestion of product.The action taken with japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009 was unknown.On an unknown date, the outcome of the dementia aggravated, wrong technique in product usage process and accidental ingestion of product were unknown.It was unknown if the reporter considered the dementia aggravated to be related to japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.This report is made by gsk/haleon without prejudice and does not imply any admission or liability for the incident or its consequences.[clinical course]: on an unknown date, the consumer soaked the removed dentures into the solution of japanese 5 minute polident in the evening, and the dentures were washed in the morning and were handed to the consumer's grandfather (patient).Thereafter, the patient seemingly developed dementia aggravated (seriousness: gsk medically significant).The patient took out the dentures form the solution himself, and wore the dentures.It was unknown if the dentures were washed.No further information is expected.

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM PERCARBONATE)-MFC51009
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15537626
• MDR Text Key: 301122917
• Report Number: 1020379-2022-00025
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male