MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA POWDER; DENTURE ADHESIVE

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Event Description

I almost choked [choking sensation].I use bridges attached to teeth/ corega: simply the powder does not stick well [wrong technique in device usage process].Case description: this case was reported by a consumer via (b)(6) interactive digital media and described the occurrence of choking sensation in a female patient who received denture adhesive powder-double salt (corega powder) oral powder (batch number unk, expiry date unknown) for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega powder.On an unknown date, an unknown time after starting corega powder, the patient experienced choking sensation (serious criteria gsk medically significant and other: gsk medically significant), wrong technique in device usage process and product complaint.The action taken with corega powder was unknown.On an unknown date, the outcome of the choking sensation, wrong technique in device usage process and product complaint were unknown.It was unknown if the reporter considered the choking sensation and wrong technique in device usage process to be related to corega powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: adverse event information was received via (b)(6) interactive digital media on (b)(6) 2021.The consumer reported that, "use bridges attached to teeth and when chewing any food they come out.Corega: simply the powder does not stick well.I start chewing the food and the bridges fall off and mix with the food in my mouth.I almost choked." information was received on (b)(6) 2021 from quality assurance (qa) department regarding complaint (b)(4) for unknown lot number.Investigation evaluation: super corega powder and ultra corega powder are specially formulated to form a tight seal and provide a firm hold for dentures.Their active adhesives are polyox (super corega) and gantrez (ultra corega) also in corega powder formulations, cmc (carboxymethylcellulose) acts as a viscosity modifier/thickener.When cmc interacts with saliva in the mouth, it provides high viscosity to the formulation promoting the adhesive strength.After performed tests with corega powder, it has been shown to be effective in providing 12 hours hold.Although, complaints for did not hold (reason code cpe dnt hold) have been received over last years.This kind of complaint can be related to differences in fitting of dentures of individual customers.When customers use dentures in condition of poor fitting, especially if there is some gap between denture and the gum, the product cannot reach expected adhesiveness.During the latest 24 months (from (b)(6) 2017 to (b)(6)2019) a total of (b)(4) complaints regarding did not hold for corega powder have been received.Response to consumer: all products manufactured at (b)(4) site released for sale at the consumer level meet acceptance criteria for quality parameters.All documentation associated with the manufacturing, packaging and testing of product is reviewed by the site quality department to verify compliance prior to product release.It was not found any observations that the problem could have been occurred within gsk.Thus, the complaint was classified as not substantiated.Complaint was concluded as unsubstantiated.Initial and qa result processed together.

Manufacturer Narrative

(b)(4).

• Brand Name: COREGA POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, NC 27709 ; 8888255249
• MDR Report Key: 13079226
• MDR Text Key: 288289511
• Report Number: 3003721894-2021-00409
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/16/2021

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: 12/16/2021
• Initial Date FDA Received: 12/23/2021
• 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
• Patient Sex: Female