MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 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 11/28/2023

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

The patient who is hospitalized swallowed the polident denture cleaner just now.[accidental device ingestion].Case description: this case was reported by a pharmacist via call center representative and described the occurrence of accidental device ingestion in a patient who received denture cleanser (polident denture cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Concurrent medical conditions included hospitalisation.On (b)(6) 2023, the patient started polident denture cleanser.On (b)(6) 2023, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria haleon medically significant) and product confusion.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion and product confusion were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser.This report is made by haleon without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was reported by a pharmacist via call center representative (phone) on 28nov2023.The consumer stated that "i am a pharmacist working in psychiatric hospital in.The patient who is hospitalized swallowed the polident denture cleaner just now.I'm contacting you because i want to know if we need to do a gastric lavage and what symptoms can occur.Also, i think this event happened because the cleanser looks similar with pill.I'd like to request you to change the shape of the product not to be like pill so that such event is not occur in the future".

• Brand Name: POLIDENT DENTURE CLEANSER
• 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: 18391886
• MDR Text Key: 331291764
• Report Number: 1020379-2023-00038
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/28/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/26/2023
• 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): Other