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 Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

[injury].Case description: this case was reported by a consumer via call center representative and described the occurrence of injury in a (b)(6) female 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 an unknown date, an unknown time after starting japanese polident for partials (with sodium percarbonate) mfc5625, the patient experienced injury (serious criteria hospitalization) and wrong technique in product usage process.The action taken with japanese polident for partials (with sodium percarbonate) mfc5625 was unknown.On an unknown date, the outcome of the injury and wrong technique in product usage process were unknown.It was unknown if the reporter considered the injury 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 started japanese polident for partials(with sodium percarbonate) mfc5625.The patient usually used japanese polident for partials (with sodium percarbonate) mfc5625 for cleansing her partial denture.On an unknown date, the subject had just run out of started japanese polident for partials (with sodium percarbonate) mfc5625 during hospitalization for injury (serious criteria hospitalization).Therefore, the patient had a person bought her polident, and the person bought polident with enzymes 48 tablets.In addition, the patient used water because she couldn't obtain tepid water during hospitalization.The patient was happy she could eat all of the hospital food because she had a dentist fixed her partial denture just recently.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
• MDR Report Key: 18442023
• MDR Text Key: 331867127
• Report Number: 1020379-2023-00040
• 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: 12/14/2023

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: 12/14/2023
• Initial Date FDA Received: 01/04/2024
• 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: 96 YR
• Patient Sex: Female