MAUDE Adverse Event Report: BLOCK DRUG CO., INC. POLIDENT PROPARTIAL FOAM CLEANSER; DENTURE CLEANSER

Lot Number 2920A1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Im choking from the fumes of it [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a patient who received denture cleanser foam (polident propartial foam cleanser) cleanser (batch number 2920a1, expiry date 15th september 2023) for product used for unknown indication.On an unknown date, the patient started polident propartial foam cleanser.On an unknown date, an unknown time after starting polident propartial foam cleanser, the patient experienced choking (serious criteria gsk medically significant and other: haleon medically significant).The action taken with polident propartial foam cleanser was unknown.On an unknown date, the outcome of the choking was unknown.The reporter considered the choking to be related to polident propartial foam cleanser.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 (b)(6) 2023.The consumer reported that, "im calling about a product that i have tried its the polident foam cleanser and i'm choking from the fumes of it.I really don't like it".

• Brand Name: POLIDENT PROPARTIAL FOAM 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: 16852968
• MDR Text Key: 314371748
• Report Number: 1020379-2023-00016
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2023
• Device Lot Number: 2920A1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• 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
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other