MAUDE Adverse Event Report: POLIGRIP FLAVOUR FREE; DENTURE ADHESIVE

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

Argus case number: (b)(4).

Event Description

This morning i choked.[choking].Felt like i swallowed a lot of it [accidental device ingestion].I was coughing and gagging [cough].I was gagging [gagging].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 60-year-old female patient who received double salt dental adhesive cream (poligrip flavour free) cream (batch number unk, expiry date unknown) for denture wearer.This case was associated with a product complaint.In (b)(6) 2023the patient started poligrip flavour free.On (b)(6) 2023, an unknown time after starting poligrip flavour free, the patient experienced choking (serious criteria haleon medically significant and other: haleon medically significant), accidental device ingestion (serious criteria haleon medically significant and other: haleon medically significant), cough and gagging.On an unknown date, the patient experienced product complaint.The action taken with poligrip flavour free was unknown.On (b)(6) 2023, the outcome of the choking, accidental device ingestion, cough and gagging were recovered/resolved.On an unknown date, the outcome of the product complaint was unknown.It was unknown if the reporter considered the choking, accidental device ingestion, cough and gagging 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 a consumer via call center representative (phone) on (b)(6) 2023.Consumer reported that "i have a complaint, it is not working the same i tried 2 different tubes and have been using it for 15 years they eventually start holding better but i have to be careful if i am biting on something hard in the morning they are oozing so bad, this morning i choked.It went in the back of my throat and i had to pull it back out, i was taking paper towels trying to get it off the roof of my mouth, i was coughing and gagging and felt like i swallowed a lot of it.Later in the night they will start loosening up in my mouth and when i pull them out the dentures are stuck to the roof of my mouth.I keep them in the door of my fridge to keep them firm (the product) but it still does not do any good, i have not put a different amount the texture is different, it is not as firm, it is nasty, oozy, sticky all day long i would like to be reimbursed, would it be like a coupon.Price - around dollar 10- dollar 11 from start date - around 2 weeks ago, still using it".Follow up information was received on (b)(6) 2023 from quality assurance (qa) department regarding product quality complaint with case number 05117081 for ud6x as lot number.Investigation evaluation: provide a firm hold for dentures.The combination of the duo salt and carboxymethylcellulose in the product provides the adhesive strength that helps hold dentures in place.Haleon denture adhesives have been shown to be effective in providing 12 hours hold across multiple randomized clinical trials.The complaints received for the reason code cpe dnt hold are of a common / expected nature for the fixative paste formulations.Prior to the generation of a cim, each cpe dnt hold customer complaint was individually investigated whereby the complaint sample was tested for the percentage of active ingredient.A batch documentation review was also performed to verify that there were no issues during the manufacture or packaging of the batch.Each investigation verified that the concentration of active material was within specification and that the product had been manufactured appropriately and complied with all required quality standards.Response to consumer (if applicable): he concentration of "active" ingredient in the lot/product in question was within specification and met all requirements of the release specification.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 and 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.As with any product, it is expected that the consumer may have different experiences based on various individual factors like the fit of the denture and the oral anatomy of the denture wearer, that may determine the performance of the denture adhesive.Please be assured that this complaint has been logged, will be indicated in the manufacturing site metrics and will be brought to the attention of all relevant site personnel as part of the complaint review process.On the basis of the above i now wish to consider this complaint closed - please revert should you require any further information.Complaint conclusion: unsubstantiated.Product complaint id reported as (b)(4).Initial and follow up processed together.

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Case description: this report is being resubmitted to capture case correction.The information was received on 25jul2023 and is as follows: updated the suspect drug start date from jul2025 to jul2023.Updated product batch number from unknown to ud6x on product device tab.

• Brand Name: POLIGRIP FLAVOUR FREE
• Type of Device: DENTURE ADHESIVE
• Manufacturer Contact: 184 liberty corner road, suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 17602236
• MDR Text Key: 321719997
• Report Number: 3003721894-2023-00138
• 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,Followup
• Report Date: 07/25/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/24/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Female