MAUDE Adverse Event Report: BLOCK DRUG CO., INC. 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  Death  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Death [unknown cause of death].Case description: this case was reported by a consumer via call center representative and described the occurrence of unknown cause of death in a female 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).On an unknown date, an unknown time after starting japanese polident for partials (polident for partials with taed), the patient experienced unknown cause of death (serious criteria death and gsk medically significant).On an unknown date, the outcome of the unknown cause of death was fatal.The reported cause of death was unknown cause of death.It was unknown if the reporter considered the unknown cause of death 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, there were plenty of partialdent, which were no longer used but used to be used to cleanse either dental corrective devices or the reporter's late mother's denture.On 21st november 2022, although initially reported as partialdent, the product was confirmed to be japanese polident for partials (polident for partials with taed).No further information is expected.

• Brand Name: JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
• 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: 16005014
• MDR Text Key: 305711813
• Report Number: 1020379-2022-00035
• 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: 11/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2022
• 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): Death; Other
• Patient Sex: Female