MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT 3 MINUTE; 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

I accidentally drank 3-4 ounces of it mixed with water [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) tablet (batch number unk, expiry date unknown) for drug use for unknown indication.On an unknown date, the patient started polident 3 minute.On an unknown date, an unknown time after starting polident 3 minute, the patient experienced accidental device ingestion (serious criteria gsk medically significant).The action taken with polident 3 minute 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.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 : adverse event information was received from a consumer via call center representative (phone) on 04oct2022.The consumer stated that "i use the polident 3 minute daily cleanser and i accidentally drank 3 to 4 ounces of it mixed with water.Do you have any advise for that.What would happen".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: POLIDENT 3 MINUTE
• 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: 15690300
• MDR Text Key: 302573716
• Report Number: 1020379-2022-00027
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/04/2022

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: 10/04/2022
• Initial Date FDA Received: 10/28/2022
• 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): Other