MAUDE Adverse Event Report: BLOCK DRUG CO., INC. JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC5625; 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 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Hospitalisation [hospitalisation].Case description: this case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a patient who received denture cleanser (japanese polident for partials(with sodium percarbonate)-mfc5625) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started japanese polident for partials (with sodium percarbonate)-mfc5625.On (b)(6) 2023, an unknown time after starting japanese polident for partials(with sodium percarbonate)-mfc5625, the patient experienced hospitalisation (serious criteria hospitalization).The action taken with japanese polident for partials(with sodium percarbonate)-mfc5625 was unknown.On an unknown date, the outcome of the hospitalisation was unknown.It was unknown if the reporter considered the hospitalisation to be related to japanese polident for partials(with sodium percarbonate)-mfc5625.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 patient, the reporter's family member, used japanese polident for partials(with sodium percarbonate)-mfc5625.On (b)(6) 2023, the patient experienced urgent hospitalisation (serious criteria hospitalization).No further information is expected.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS(WITH SODIUM PERCARBONATE)-MFC5625
• 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: 18158438
• MDR Text Key: 328355844
• Report Number: 1020379-2023-00036
• 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: 11/06/2023

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: 11/06/2023
• Initial Date FDA Received: 11/17/2023
• 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