MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA DENTURE ADHESIVE CREAM

Lot Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Event Description

It goes to my throat, i'm choking [choking].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a male patient who received double salt dental adhesive cream (corega denture adhesive cream) cream for denture wearer.On an unknown date, the patient started corega denture adhesive cream.On an unknown date, an unknown time after starting corega denture adhesive cream, the patient experienced choking (serious criteria haleon medically significant and other: haleon medically significant) and product complaint.The action taken with corega denture adhesive cream was unknown.On an unknown date, the outcome of the choking and product complaint were unknown.The reporter considered the choking to be related to corega denture adhesive cream.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 (phone) on 14feb2024.It was reported that; "have a nice day.I was buying 3 corega a month.It used to be very beautiful.Could you please connect me with an authorized person? i understand it doesn't hold, it goes to my throat, i'm choking.Last year was better.I have been using it for 15-20 years.The quality has decreased and it does not stick.We eat but we cannot eat.Please put more adhesive.We pay 130-140 lira.We do not want to make bad propaganda.It goes into my throat and i'm choking.That's why it doesn't hold.It doesn't stick.It's not just me, it's just my friends who don't like it the same way either.Another brand comes out and no one uses corega again.By my side.Does not contain corega tat.I just applied it again and it still holds.The dentist doesn't deal with this.The dentist also said that there were complaints.Are you talking about the tube? i can't see anything, it's not readable here.I've been using it since it came out.I can not see.Quality has dropped.You're welcome i'm always waiting for it to get better.A lot of products came out.No one is of any use.I know which one sticks more.It goes down my throat and i'm choking.Is it free? i am a guest.When will this product arrive? at the beginning of march.We pay 500 lira a month.You're welcome.Enjoy your work.".Follow up information was received on 14feb2024 from quality assurance department (qa) regarding complaint number (b)(4) for unknown batch number.Investigation evaluation: denture adhesive creams are specially formulated to form a tight seal and 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): the 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 & 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.The product complaint was concluded as unsubstantiated.Product complaint number was reported as (b)(4).Initial and follow up qa report are processed together.

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: COREGA DENTURE ADHESIVE CREAM
• 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: 18766427
• MDR Text Key: 336061036
• Report Number: 3003721894-2024-00025
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 02/14/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 02/23/2024
• 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: NO THERAPY (NO THERAPY).
• Patient Outcome(s): Other
• Patient Sex: Male