MAUDE Adverse Event Report: 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 03/01/2024

Event Type  Injury  

Event Description

It got stuck in his throat at first [medication stuck in throat] he would feel sour in his throat [throat discomfort] his head would feel dizzy [dizziness] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a elderly male patient who received denture cleanser (polident denture cleanser) tablet (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident denture cleanser.On (b)(6) 2024, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria haleon medically significant), medication stuck in throat (serious criteria haleon medically significant), throat discomfort and dizziness.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion, medication stuck in throat, throat discomfort and dizziness were unknown.The reporter considered the medication stuck in throat to be related to polident denture cleanser.It was unknown if the reporter considered the throat discomfort and dizziness 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: the adverse event information was received from consumer via call center representative (phone) on (b)(6) 2024.The consumer reported that "my dad is in his (b)(6) (no specific age provided).This morning when he was eating at 7:30, he accidentally swallowed one polident denture cleanser.It got stuck in his throat at first.He said he would feel sour in his throat, and then his head would feel dizzy.He should swallow it completely.But the otolaryngology department is not open yet this morning.What should i do? want to see a doctor? which subject should i pass? can it be relieved by drinking a lot of water? what are the specifications of polident denture cleanser? is it available in 36 tablets? my dad is supposed to be using a box of polident denture cleanser 36 tablets, but he and i don't live together, so i don't know the batch number and expiry date of the product.Are the ingredients in polident denture cleanser 36 tablets inedible".

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: POLIDENT DENTURE CLEANSER
• Type of Device: DENTURE CLEANSER
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18883724
• MDR Text Key: 337404067
• Report Number: 1020379-2024-00005
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/01/2024

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
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/12/2024
• 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
• Patient Sex: Male