MAUDE Adverse Event Report: GLAXOSMITHKLINE COREGA ULTRA POWDER; DENTURE ADHESIVE

Model Number WU2U

Device Problem Product Quality Problem (1506)

Patient Problems Pyrosis/Heartburn (1883); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Sometimes swallows the product, accidental device ingestion.Feeling heartburn.Feels the mouth is on fire, burning oral sensation.Lost his taste.Apply again the product, device used for unapproved schedule.Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a adult male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number ma6h, expiry date 31st january 2027) for product used for unknown indication.Co-suspect products included denture adhesive powder-double salt (corega ultra powder) oral powder (batch number wu2u, expiry date april 2026) for product used for unknown indication.On an unknown date, the patient started corega ultra powder and corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder and corega ultra powder, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), heartburn, burning oral sensation, taste loss, device used for unapproved schedule and product complaint.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the accidental device ingestion, heartburn, burning oral sensation, taste loss, device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, heartburn, burning oral sensation, taste loss and device used for unapproved schedule to be related to corega ultra powder and corega ultra 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 : this case was reported from consumer via call center representative (email) on 27may2022.The consumer stated that, "a consumer reported that is using corega ultra and that after several months filling for product complaint he lost the taste, the stomach burns and feels the mouth is on fire.In one occasion the consumer had even to apply again the product because the denture was unstick.The consumer also referred that sometimes he swallows the product because the product is too soft and drips.This ae form is associated to a pqc (case (b)(4))." follow up information was reported from consumer via call center representative (email) on 27may2022.The consumer stated that, "hello, mr.Contacted us this morning regarding the corega ultra product.He said that he has been sending emails about this product for 7/8 months and that he does not get a response.The product has changed formula and since then his dental appliance does not hold.The patient even said that the product is absolutely useless and that it runs and softens and that because of this he sometimes swallows the product.The patient said that for several months he has been feeling heartburn, his mouth is on fire and he has lost his taste.Please contact the patient urgently as they are still awaiting a response from gsk.This complaint has an associated pharmacovigilance case (01501643, ae-58535).Corega ultra lot ma6h expiration date 2027/01 lot wu2u, expiration date 2026/04.No new information reported.Initial and follow up information were processed together.

Manufacturer Narrative

Argus case id: (b)(6).

Event Description

Sometimes swallows the product [accidental device ingestion].Feeling heartburn/the stomach burns [heartburn].Feels the mouth is on fire [burning oral sensation].Lost his taste [taste loss].Apply again the product [device used for unapproved schedule].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a adult male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number ma6h, expiry date 31st january 2027) for product used for unknown indication.Co-suspect products included denture adhesive powder-double salt (corega ultra powder) oral powder (batch number wu2u, expiry date april 2026) for product used for unknown indication.On an unknown date, the patient started corega ultra powder and corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder and corega ultra powder, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), heartburn, burning oral sensation, taste loss, device used for unapproved schedule and product complaint.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the accidental device ingestion, heartburn, burning oral sensation, taste loss, device used for unapproved schedule and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion, heartburn, burning oral sensation, taste loss and device used for unapproved schedule to be related to corega ultra powder and corega ultra 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 : this case was reported from consumer via call center representative (email) on (b)(6) 2022.The consumer stated that, "a consumer reported that is using corega ultra and that after several months filling for product complaint he lost the taste, the stomach burns and feels the mouth is on fire.In one occasion the consumer had even to apply again the product because the denture was unstick.The consumer also referred that sometimes he swallows the product because the product is too soft and drips.This ae form is associated to a pqc (b)(4)." follow up information was reported from consumer via call center representative (email) on (b)(6) 2022.The consumer stated that, " contacted us this morning regarding the corega ultra product.He said that he has been sending emails about this product for 7/8 months and that he does not get a response.The product has changed formula and since then his dental appliance does not hold.The patient even said that the product is absolutely useless and that it runs and softens and that because of this he sometimes swallows the product.The patient said that for several months he has been feeling heartburn, his mouth is on fire and he has lost his taste.Please contact the patient urgently as they are still awaiting a response from gsk.This complaint has an associated pharmacovigilance (b)(4).Corega ultra lot ma6h expiration date 2027/01 lot wu2u, expiration date 2026/04.No new information reported.Initial and follow up information were processed together.Follow up information was reported from consumer via call center representative (email) on (b)(6) 2022.No new information received.The consumer reported that" do not know yet if my health is due to your product, am in treatment but since you changed the formula about 1 year ago, your new formula is catastrophic.The dental appliances do not hold, as soon as you eat or drink the appliance does not hold, the product becomes soft and you are full o tit in your mouth, wheres's with the corega ulta 1 year ago it was perfect i used it for about 20 years 1 now use ajustent from laboratories it's very good l1 recommend it to my acquaintances, who are delighted it's a shame you had a paffait product.".Correction done on initial case received on (b)(6) 2022.Expirey date of corega ultra powder was updated to jan 2027 from 31jan2027.(b)(6) initially received on 27may2022 is a duplicate of (b)(6).All future correspondence will be submitted to (b)(6).Follow up information was received from quality assurance (qa) department on (b)(6) 2022 regarding complaint (b)(4) (issue number) for lot number ma6h.Additional details: this pqc has been reported by safety - site visibility 06sep, due date 21sep, case is not overdue by site.Investigation evaluation: this is the first complaint of this nature for this batch.A notification review check was carried out on this batch which relates to manufacturing deviations, vendor investigations, change controls and laboratory investigations, there were no issues noted during the manufacture of this batch as per the defect of this complaint received.Therefore no further actions will be taken at this time.Based on the investigation performed by the site the complaint was concluded unsubstantiated.The pqc number was reported as pqc158812.Follow up information was received from quality assurance (qa) department on (b)(6) 2022 regarding complaint (b)(4) (issue number) for lot number wu2u.Additional details:this pqc has been reported by safety - the reason why the pqc is logged today-(b)(6) 2022.Site visibility on the 6th 09 case not overdue for site.Investigation evaluation:this is the first complaint of this nature for this batch.A notification review check was carried out on this batch which relates to manufacturing deviations, vendor investigations,change controls and laboratory investigations, there were no issues noted during the manufacture of this batch as per the defect of this complaint received.Therefore no further actions will be taken at this time.The testing of a retain for this lot was performed.The testing of the complaint retain sample has met the required quality standards.No further action will be taken.The investigation report concluded the complaint as an unsubstantiated.The pqc number was reported as pqc158815.Follow up information was received from quality assurance (qa) department on (b)(6) 2022 regarding complaint (b)(4) (issue number) for lot number wu2u.No new information was added to case.Follow up 4 and 5 processed together.

• Brand Name: COREGA ULTRA POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE; dungarvan ltd; waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 14754063
• MDR Text Key: 294574953
• Report Number: 3003721894-2022-00075
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 05/27/2022

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
• Device Model Number: WU2U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/27/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 09/16/2022
• Supplement Dates FDA Received: 10/11/2022
• 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
• Patient Sex: Male