MAUDE Adverse Event Report: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED); 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

Hospitalization [hospitalization].This case was reported by a consumer via call center representative and described the occurrence of hospitalisation in a 86-year-old male patient who received denture cleanser (japanese polident for partials (polident for partials with taed)) tablet for denture wearer.Concurrent medical conditions included denture wearer.On an unknown date, the patient started japanese polident for partials (polident for partials with taed).In 2022, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced hospitalisation (serious criteria hospitalization).On an unknown date, the patient experienced wrong technique in product usage process.The action taken with japanese polident for partials (polident for partials with taed) was unknown.On an unknown date, the outcome of the hospitalisation and wrong technique in product usage process were unknown.It was unknown if the reporter considered the hospitalization to be related to japanese polident for partials (polident for partials with taed).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 (polident for partials with taed) by dissolving 2 tablets in 250 ml of cold water in a large glass.In 2022, the patient experienced hospitalization (serious criteria hospitalization) in the summer.On an unknown date, the patient was hospitalized from the summer until recently.After being discharged from the hospital, he used japanese polident for partials (polident for partials with taed) by dissolving 2 tablets in 150 ml of cold water in a polident cup, which he had had brought from the hospital.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
• Type of Device: DENTURE CLEANSER
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15885912
• MDR Text Key: 304521366
• Report Number: 1020379-2022-00032
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): Y
• 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: 11/07/2022

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: 11/07/2022
• Initial Date FDA Received: 11/30/2022
• 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): Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male