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

Device Problem Product Quality Problem (1506)

Patient Problem Paresthesia (4421)

Event Date 09/10/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Felt a tingling feeling in my ears [tingling sensation].Tingle in my lips/ tingle in my tongue [tingling mouth].Swelling as getting significantly worse [swelling].I was struggling to breath [difficulty breathing].Case description: this case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a male patient who received double salt dental adhesive cream (polident denture adhesive cream fresh mint) cream (batch number unk, expiry date 31st october 2024) for denture wearer.This case was associated with a product complaint.On (b)(6) 2022, the patient started polident denture adhesive cream fresh mint.On (b)(6) 2022, less than a day after starting polident denture adhesive cream fresh mint, the patient experienced tingling sensation (serious criteria hospitalization and other: haleon medically significant), tingling mouth (serious criteria hospitalization and other: haleon medically significant), swelling (serious criteria hospitalization and other: haleon medically significant) and difficulty breathing (serious criteria hospitalization and other: haleon medically significant).On an unknown date, the patient experienced inappropriate schedule of product administration and product complaint.The action taken with polident denture adhesive cream fresh mint was unknown.On an unknown date, the outcome of the tingling sensation, tingling mouth, difficulty breathing, inappropriate schedule of product administration and product complaint were unknown and the outcome of the swelling was recovering/resolving.It was unknown if the reporter considered the tingling sensation, tingling mouth, swelling and difficulty breathing to be related to polident denture adhesive cream fresh mint.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 consumer via call center representative (email) on 19oct2022.Consumer reported that "i am writing to make you aware of an issue that i have experienced recently.Over the weekend of (b)(6) i was attending a dart tournament in.On the saturday afternoon i had cause to reapply polident to my bottom denture as i usually use it twice a day.I applied the polident and noticed an unusual taste but did not think anything of it as i had not eaten for several hours and thought that may have been why.Several minutes later i felt a tingling feeling in my ears followed by a tingle in my lips and tongue.These progresses quickly and i asked to be driven to the hospital.Upon arrival the swelling as getting significantly worse and i was struggling to breath.I was taken to casualty and given adrenalin to subdue what was described as a reaction.What followed was two more injections before the swelling started to subside.I spent the night in hospital and was released in the sunday.I examined the polident tube and found a very acid smell coming from the tube.I proceeded to check all of the tubes i had and found another tube with the same smell.I have used polident for more than 10 years and have never experienced an issue such as this.I am using it again now.However i also know that these tubes have spoiled in some way and feel that this is inappropriate.Your product is expensive and i have wasted two tubes through no fault of my own.I have included pics of the batch numbers.Your response is eagerly awaited".The follow up was received on 21oct2022 by quality assurance department for complaint number (b)(4) for unk lot number.Investigation evaluation: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a [?]batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Due to the adverse event and related hsi, could i kindly request that further information is requested from the complainant.A photograph was received to site but the lot details or detail of the defect was not evident in the photograph provided to allow further investigation.Complaint conclusion:based on the investigation performed, the complaint is found to be unsubstantiated.The follow up was received on 21oct2022 by quality assurance department for complaint number (b)(4) for unk lot number.Investigation evaluation: no sample was returned for this complaint, also batch details were not received so a full investigation could not be completed.As this information is not available the complaint cannot be substantiated.All of the documentation pertinent to a specific lot of finished product is contained in a batch envelope'.Prior to the disposition of the product, the contents of each batch envelope is reviewed & approved by the site quality department to verify that there were no significant quality issues recorded during manufacturing, packaging or testing.This review also verifies that all test results meet specification requirements.Due to the adverse event and related hsi, could i kindly request that further information is requested from the complainant.A photograph was received to site but the lot details or detail of the defect was not evident in the photograph provided to allow further investigation.Complaint conclusion: based on the investigation performed, the complaint is found to be unsubstantiated.The follow up 1 and 2 are processed together.

• Brand Name: POLIDENT DENTURE ADHESIVE CREAM FRESH MINT
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; durgarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 15771700
• MDR Text Key: 303427548
• Report Number: 3003721894-2022-00166
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): Y
• Reporter Country Code: AS
• 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: 10/19/2022

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/19/2022
• Initial Date FDA Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Sex: Male