MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE DENTURE CLEANSER TABLET

Lot Number 9U30

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 04/10/2023

Event Type  Injury  

Event Description

Accidentally swallowed one of your pills [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 patient who received denture cleanser (polident 3 minute denture cleanser tablets) tablet (batch number 9u30, expiry date 30th august 2023) for drug use for unknown indication.On an unknown date, the patient started polident 3 minute denture cleanser tablets.On (b)(6)2023, an unknown time after starting polident 3 minute denture cleanser tablets, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident 3 minute denture cleanser tablets 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 3 minute denture cleanser tablets.This report is made by gsk/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)2023 and consumer reported that"i accidentally swallowed one of your pills the ones you use to clean your dentures with, polident micro clean formula 99%.9u30, 2023/8/30".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT 3 MINUTE DENTURE CLEANSER TABLET
• 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: 16896617
• MDR Text Key: 314842695
• Report Number: 1020379-2023-00018
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/30/2023
• Device Lot Number: 9U30
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/10/2023
• 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