MAUDE Adverse Event Report: BLOCK DRUG CO., INC. SOKAI JIKKAN POLIDENT WITH SODIUM PERCARBONATE-MFC51038; 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 Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Hospitalisation [hospitalisation].Lip swelling [lip swelling].Blood pressure increased [blood pressure increased].Dyspnoea [dyspnoea].Case description: this case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a 90-year-old female patient who received denture cleanser (sokai jikkan polident with sodium percarbonate-mfc51038) tablet for an unknown indication.Concurrent medical conditions included dementia.On an unknown date, the patient started sokai jikkan polident with sodium percarbonate-mfc51038.On an unknown date, an unknown time after starting sokai jikkan polident with sodium percarbonate-mfc51038, the patient experienced hospitalisation (serious criteria hospitalization), lip swelling, blood pressure increased, dyspnoea and accidental ingestion of product.The action taken with sokai jikkan polident with sodium percarbonate-mfc51038 was unknown.On an unknown date, the outcome of the hospitalisation, lip swelling, blood pressure increased and dyspnoea were recovered/resolved and the outcome of the accidental ingestion of product was unknown.It was unknown if the reporter considered the hospitalisation, lip swelling, blood pressure increased and dyspnoea to be related to sokai jikkan polident with sodium percarbonate-mfc51038.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 reporting consumer's mother (she) consumed sokai jikkan polident with sodium percarbonate-mfc51038 10 tablets, and experienced lip swelling (seriousness: non-serious).The reporting consumer called the japan poison information center (center).The center staff told the reporting consumer that the amount of accidental ingestion of product was too much.Therefore, she was transported by ambulance and eventually admitted to the hospital (seriousness: hospitalization).In the ambulance, her blood pressure measured over 200 (seriousness: non-serious), and she had dyspnoea (seriousness: non-serious).The product was sokai jikkan polident with sodium percarbonate-mfc51038 108 tablets.On an unknown date, the symptom subsided, and she was discharged from the hospital.

• Brand Name: SOKAI JIKKAN POLIDENT WITH SODIUM PERCARBONATE-MFC51038
• 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: 18180184
• MDR Text Key: 328615451
• Report Number: 1020379-2023-00037
• 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: 11/10/2023

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/21/2023
• 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: 90 YR
• Patient Sex: Female