MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIDENT DENTURE ADHESIVE CREAM FRESH MINT

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

Every day i use it like this, i will eat a little bit of the adhesive [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 71-year-old male patient who received denture cleanser (polident denture cleanser) tablet (batch number unk, expiry date unknown) for product used for unknown indication.Co-suspect products included double salt dental adhesive cream (polident denture adhesive cream fresh mint) cream (batch number unk, expiry date unknown) for denture wearer.On an unknown date, the patient started polident denture cleanser and polident denture adhesive cream fresh mint.On an unknown date, an unknown time after starting polident denture cleanser and polident denture adhesive cream fresh mint, the patient experienced accidental device ingestion (serious criteria haleon medically significant) and expired product administered.The action taken with polident denture cleanser was unknown.On an unknown date, the outcome of the accidental device ingestion and expired product administered were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to polident denture cleanser and polident denture adhesive cream fresh mint.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 the consumer via call center representative (phone) on (b)(6) 2024.Reporter stated that "i have been using polident denture adhesive cream fresh mint 60g for 6-7 years.Every day i use it like this, i will eat a little bit of the adhesive, will it affect my body, if i use less, it will not stick well, and sometimes when i use too much, the adhesive will squeeze out when i wear it.Soak with polident denture cleanser tablet 72 tablets all night, and take it up in the morning, is this, okay? can i use this product after the expiration date? i bought a lot of boxes at a time, but i don't use it every day, i only use it once a day.I now realize that the product has expired, and i am still using it after expiration date.I only use it once in a while, and i use this cleanser tablet because i hope it can clean my dentures, and they are really cleaner after using it.This box is also quite expensive, there are six tablets in one piece.(lot[?]7p2v mfg[?]2020.9 exp[?]2022.8 1)".

Manufacturer Narrative

Argus case:(b)(4).

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM FRESH MINT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059
• MDR Report Key: 18683183
• MDR Text Key: 335073021
• Report Number: 3003721894-2024-00016
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 01/30/2024

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: 01/30/2024
• Initial Date FDA Received: 02/12/2024
• 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
• Patient Age: 71 YR
• Patient Sex: Male