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 Type  Injury  

Event Description

My wife is recuperating and she swallowed the polident cleanser which was put on the table thinking it was a medicine.[accidental device ingestion] case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a female patient who received denture cleanser (polident denture cleanser) unknown for drug use for unknown indication.On an unknown date, the patient started polident denture cleanser at an unknown dose and frequency.On an unknown date, an unknown time after starting polident denture cleanser, the patient experienced accidental device ingestion (serious criteria haleon medically significant).The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion was 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: the adverse event information was received from consumer via call center representative (phone) on 15sep2023 and consumer reported that"my wife is recuperating and she swallowed the polident cleanser which was put on the table thinking it was medicine.Is it okay to swallow polident cleanser".

Manufacturer Narrative

Argus case: (b)(4).

• 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: 17867748
• MDR Text Key: 324878791
• Report Number: 1020379-2023-00033
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2023

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
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/04/2023
• 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
• Patient Sex: Female