MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

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  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I got mixed the cup and the solution cup.I drank some of it.[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 polident (polident (unspecified denture adhesive or denture cleanser)) unknown (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started polident (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting polident (unspecified denture adhesive or denture cleanser), the patient experienced accidental device ingestion (serious criteria haleon medically significant and other: haleon medically significant).The action taken with polident (unspecified denture adhesive or 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 (unspecified denture adhesive or 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 received from consumer via call center representative (phone) on (b)(6) 2023 and reported that "i am calling about polident.I just used some for my denture this morning.After i finished and discarded the solution in the cup.I got mixed the cup and the solution cup.I drank some of it.Would i need to do something".

• Brand Name: POLIDENT (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): BLOCK DRUG CO., INC.; memphis TN
• Manufacturer Contact: 184 liberty corner road, suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 18071442
• MDR Text Key: 327354297
• Report Number: 1020379-2023-00035
• 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: 10/18/2023

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: 10/18/2023
• Initial Date FDA Received: 11/06/2023
• 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
• Treatment: NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other