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

Lot Number 126359

Device Problem Product Quality Problem (1506)

Patient Problem Discomfort (2330)

Event Date 05/16/2022

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Possibly mild poisoning, poisoning.If swallowed accidentally, accidental device ingestion.Causes irritation, discomfort.Negative effect appeared/he gets side effects.Ill-defined disorder.Case description: this case was reported by a consumer via call center representative and described the occurrence of poisoning in a 79-year-old patient who received double salt dental adhesive cream (corega comfort gel) cream (batch number 126359, expiry date july 2022) for denture wearer.This case was associated with a product complaint.On (b)(6) 2022, the patient started corega comfort gel.On (b)(6) 2022, 1 days after starting corega comfort gel, the patient experienced poisoning (serious criteria gsk medically significant and other: gsk medically significant), accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), discomfort and ill-defined disorder.On an unknown date, the patient experienced product complaint.On an unknown date, the outcome of the poisoning, accidental device ingestion, discomfort and ill-defined disorder were recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the poisoning, accidental device ingestion, discomfort and ill-defined disorder to be related to corega comfort gel.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 received from the consumer via call center representative (email) on (b)(6) 2022.Consumer stated ".In (b)(6) 2022, i bought 40 g of corega under the chip cream at the pharmacy a new adaptagrip technology discomfort.The tube is labeled with the extruded number 126359 and expiry date jul2022.On the package, several information about the manufacturing times are attached to each other (06aug2020,18feb2021).Now, about the substance.The tube contains a white mass, that not only doesn't stick to the denture, but doesn't keep it.After the first bite, it collapses and oozes over the prosthesis.There is no adhesive process at all.But, even worse, this white mass turns into white river sand (similar) and, if accidentally swallowed, causes irritation and possibly mild poisoning.It turns out that something is being wrecked somewhere in your supply chain.Your company should be on guard.Try to figure it out and let me know how to deal with your product next." follow up information received on 31may2022 from the consumer.The consumer reported that "i'm surprised by and resentful of your reaction to my letter with a complaint about a product of poor quality.Please read a simple consumer complaint carefully.You questioned me instead of answering my question what to do with this bad stuff called corega.It is improper.In addition, i am confident that this will not help to break through your bureaucracy.I bought the product and started using it immediately on (b)(6) 2022.The negative effect appeared on the second day.Nothing worries me, i threw the corega in the trash.I used the product once a day.I did not go to the doctor.I bought the product in the city in a pharmacy.I do not remember the name i used it according to the instructions.Yes, for the first time i felt this bad stuff in comparison with another corega product that i have been using for more than one year.The product was stored in a closed tube.I used the cap immediately after use [of cream].I inform you that i threw this corega away.Please pay attention to the information on the packaging in my letter about the production period and the batch number.You are probably afraid of your poor quality work, or crooks from pharmacies got involved in this technology, getting rid of an expired product or a fake.I thought i could get advice from you, but alas i lost confidence in the company".Initial (b)(6) and (b)(6) 1 were processed together.

Event Description

Case description: this case was reported by a consumer via call center representative and described the occurrence of poisoning in a 79-year-old patient who received double salt dental adhesive cream (corega comfort gel) cream (batch number: 126359, expiry date: july 2022) for denture wearer.This case was associated with a product complaint.On (b)(6) 2022, the patient started corega comfort gel.On (b)(6) 2022, 1 days after starting corega comfort gel, the patient experienced poisoning (serious criteria gsk medically significant and other: gsk medically significant), accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant), discomfort and ill-defined disorder.On an unknown date, the patient experienced product complaint.On an unknown date, the outcome of the poisoning, accidental device ingestion, discomfort and ill-defined disorder were recovered/resolved and the outcome of the product complaint was unknown.It was unknown if the reporter considered the poisoning, accidental device ingestion, discomfort and ill-defined disorder to be related to corega comfort gel.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 received from the consumer via call center representative (email) on 30may2022.Consumer stated ".On (b)(6) 2022, i bought 40 g of corega under the chip cream at the pharmacy a new adaptagrip technology discomfort.The tube is labeled with the extruded number: 126359 and expiry date: jul2022.On the package, several information about the manufacturing times are attached to each other (06aug2020,18feb2021).Now, about the substance.The tube contains a white mass, that not only doesn't stick to the denture, but doesn't keep it.After the first bite, it collapses and oozes over the prosthesis.There is no adhesive process at all.But, even worse, this white mass turns into white river sand (similar) and, if accidentally swallowed, causes irritation and possibly mild poisoning.It turns out that something is being wrecked somewhere in your supply chain.Your company should be on guard.Try to figure it out and let me know how to deal with your product next." follow up information received on 31may2022 from the consumer.The consumer reported that"i'm surprised by and resentful of your reaction to my letter with a complaint about a product of poor quality.Please read a simple consumer complaint carefully.You questioned me instead of answering my question what to do with this bad stuff called corega.It is improper.In addition, i am confident that this will not help to break through your bureaucracy.1.I bought the product and started using it immediately on (b)(6) 2022.2.The negative effect appeared on the second day.3.Nothing worries me - i threw the corega in the trash.4.I used the product once a day.5.I did not go to the doctor.6.I bought the product in the city in a pharmacy.I do not remember the name, 7.I used it according to the instructions.8.Yes, for the first time i felt this bad stuff in comparison with another corega product that i have been using for more than one year.8.The product was stored in a closed tube.I used the cap immediately after use [of cream].I inform you that i threw this corega away.Please pay attention to the information on the packaging in my letter about the production period and the batch number.You are probably afraid of your poor quality work, or crooks from pharmacies got involved in this technology, getting rid of an expired product or a fake.I thought i could get advice from you, but alas.I lost confidence in the company".Initial sd and fu 1 were processed together.Follow up 2 information was received on 26jul2022 from quality assurance(qa) department regarding complaint: (b)(4) for lot number: (126359).Investigational evaluation: consistency is tested on each bulk batch before filling.Also, texture is assessed during appearance testing on bulk and filled product.Both parameters were within specifications for all batches.The batch documentation of complaint samples was checked, and no deviations found for uncharacteristic texture or consistency.Complaint: a slight oiling out of the adhesive cream is normal and is intensified by warm storage.When squeezing the tube, the liquid part comes first which could give the impression of too wet.To prevent the cream from oiling out, the tube might be kneaded well before use.A dry consistency can be caused by improper use.The penetration of liquid can lead to hardening of the adhesive cream, therefore its important keeping the opening of the tube clean and dry and be carefully closed directly after use.Complaints received for texture too wet or uncharacteristic or too dry are common and expected.Therefore, these complaints are considered as unsubstantiated.The investigational reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).Follow up 2 information was received on 26jul2022 from quality assurance(qa) department regarding complaint: (b)(4) for lot number: (126359).Investigational evaluation: adhesive strength is tested on each bulk batch before filling.Adhesion strength was within specification for al batches.The batch documentation of complaint samples was checked and no deviations found which could have a negative impact to the adhesive strength.According to etol's many years of experience in manufacturing of adhesive creams.It is known that adhesion depends on several aspects of the individual consumer, e.G.Eating behavior, condition of the jaw (prosthesis, ph of saliva).Therefore, the complaint is considered as unsubstantiated.The investigational reports concluded that, complaint stands unsubstantiated.The pqc number was reported as (b)(4).

Manufacturer Narrative

Argus case: (b)(4).

• Brand Name: COREGA COMFORT GEL
• 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: 14752027
• MDR Text Key: 294385496
• Report Number: 3003721894-2022-00077
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 05/30/2022

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 Lot Number: 126359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 79 YR