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

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

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

Event Date 01/08/2021

Event Type  Injury  

Event Description

Oral mucosal blistering [oral mucosal blistering].Salivary hypersecretion [salivation].Blister [blister].Lip swelling [lip swelling].Tongue discolouration [tongue white].Swollen tongue [swollen tongue].Case description: this case was reported by a non-health professional via licensee and described the occurrence of oral mucosal blistering in a patient with unknown age and gender who received denture cleanser (japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009) tablet for denture wearer.Concurrent medical conditions included denture wearer and living in residential institution.On an unknown date, the patient started japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009.On an unknown date, after starting japanese 5 minute polident (enzyme with sodium percarbonate)-mfc51009, the patient experienced blister (serious criteria hospitalization), oral mucosal blistering (serious criteria hospitalization), salivation (serious criteria hospitalization), 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 oral mucosal blistering, salivation, blister, wrong technique in product usage process and accidental ingestion of product were unknown.It was unknown if the reporter considered the oral mucosal blistering, salivation and blister 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].Gender/age: unknown.On an unknown date, the patient in the residential institution seemingly did not rinse the dentures soaked in japanese 5 minute polident solution, and wore the dentures in the mouth.Then, the patient experienced oral mucosal blistering (seriousness: hospitalized).As the result, blister due to salivation appeared on the neck and the patient was hospitalized (seriousness: hospitalization).Follow-up information received from the reporting non-health professional on 17-jan-2023.[clinical course].Patient: 89-year old, female.On (b)(6) 2023, the patient in the residential institution seemingly did not rinse the dentures soaked in japanese 5 minute polident solution, and wore the dentures in the mouth.Then, the patient experienced oral mucosal blistering (seriousness: hospitalized).As the result, blister due to salivation appeared on the neck and the patient was hospitalized (seriousness: hospitalization).The oral mucosal blistering was observed.Around 9 o'clock, the mouth was full of blisters.In addition, the patient experienced lip swelling, tongue white and swollen tongue (seriousness: hospitalization).When the patient went to hospital a, the patient was anesthetized and intubated to secure the airway.The mucus was checked, and it was informed that the mucus was alkaline.The cup was sterilized once a week with alkaline mono-heiter.Considering another matter, the dentures were soaked in 5 minute polident solution.As of on (b)(6) 2023, the patient was hospitalized in another hospital at that point.No further information is expected.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: JAPANESE 5 MINUTE POLIDENT (ENZYME WITH SODIUM (CONTINUED)
• Type of Device: DENTURE CLEANSER
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road,; suite 200; warren, NJ 07509 ; 8888255249
• MDR Report Key: 16372268
• MDR Text Key: 309496681
• Report Number: 1020379-2023-00004
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2023
• 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): Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female