MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD POLIGRIP FLAVOUR FREE; DENTURE ADHESIVE

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I gag so bad its still all choke i almost throw up [choking].I almost throw up [nausea].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number unk, expiry date 31st december 2025) for denture failure.This case was associated with a product complaint.On an unknown date, the patient started poligrip flavour free.On an unknown date, an unknown time after starting poligrip flavour free, the patient experienced choking (serious criteria haleon medically significant and other: haleon medically significant), gagging, nausea and product complaint.The action taken with poligrip flavour free was unknown.On an unknown date, the outcome of the choking, gagging, nausea and product complaint were unknown.It was unknown if the reporter considered the choking, gagging and nausea to be related to poligrip flavour free.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 (email) on 12aug2023.It was reported that "i have been buying poliprip for 15 years and have never had some bad tube like i have been getting to take my teeth out at night i gag so bad its still all choke i almost throw up i am not sure if it was the batch or what's going on but this is not right my teeth move in my mouth all day there not strong at all i use the super poligrip the green one." follow up information was received on 23aug2023 from quality assurance (qa) department regarding (b)(4) complaint (b)(4) (case number) for unknown lot number.A sample was not returned but photographs of the defect have been provided.The batch number provided is invalid and the lot details are not evident in the photographs provided.On this basis we are unable to investigate this complaint further.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 related hsi and averse event associated with this case may i kindly request that further information be requested from the complainant.Should valid lot details be confirmed the case will be opened and further investigate will be performed on site.The investigation report concluded that the complaint stands unsubstantiated.

• Brand Name: POLIGRIP FLAVOUR FREE
• 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 ; 8888255249
• MDR Report Key: 17709350
• MDR Text Key: 322927241
• Report Number: 3003721894-2023-00151
• Device Sequence Number: 1
• Product Code: KOT
• 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: 08/12/2023

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: 08/12/2023
• Initial Date FDA Received: 09/08/2023
• 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