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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Argus case : (b)(4).

Event Description

Tongue has been burned a little [burning tongue], tongue slightly reddened [tongue redness], tiny glands under her tongue have become purple [tongue discoloration], red spots, [round red sites], at the end of the tongue [bumps tongue], herpes on her [upper] lip [herpes on lip], burning sensation in her throat [throat burning sensation of], feels something in the back of her tongue [tongue discomfort], apply a small amount in the afternoon too.[intentional device misuse].Case description: this case was reported by a consumer via call center representative and described the occurrence of burning tongue in a (b)(6) year-old female patient who received double salt dental adhesive cream (corega denture adhesive cream) cream (batch number unk, expiry date unknown) for denture wearer.Co-suspect products included double salt dental adhesive cream (corega neutral) cream (batch number l82d, expiry date 31st january 2023) for denture wearer.Concomitant products included no therapy.On an unknown date, the patient started corega denture adhesive cream and corega neutral.On an unknown date, an unknown time after starting corega denture adhesive cream and corega neutral, the patient experienced burning tongue (serious criteria gsk medically significant), tongue redness, tongue discoloration, bumps tongue, herpes on lip, throat burning sensation of and intentional device misuse.On an unknown date, the outcome of the burning tongue, tongue redness, tongue discoloration, bumps tongue, herpes on lip, throat burning sensation of and intentional device misuse were unknown.It was unknown if the reporter considered the burning tongue, tongue redness, tongue discoloration, bumps tongue, herpes on lip, throat burning sensation of and intentional device misuse to be related to corega denture adhesive cream and corega neutral.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: the case was reported by consumer via call centre representative on 01 feb 2021.It was reported that she has been using the red corega for many years, she did not know its exact name, nor did she have any old packaging.She did not have any problems with it, only sometimes, when she put it on, she felt a burning sensation in her throat.Three weeks ago, she bought corega neutral, and her tongue slightly reddened and it is like it has been burned a little, and the tiny glands under her tongue have become purple.On friday, when she looked deeper, she saw that it has caused her red spots, [round red sites], at the end of the tongue.She wanted to ask if all these could have been caused by corega.She was not sure if corega caused them all because she has generally been using corega for years.Also, corega neutral sometimes does not hold, and she has to apply a small amount in the afternoon too.She mentioned that at that time, she also had herpes on her [upper] lip, and she had also applied something for it.Follow up information received on 08 feb 2021 from the consumer.The reporter will visit her dentist this week and agreed to be contacted next week for hcp contacts.The reporter explained that she is not sure if the aes were caused by corega as she was using some cream for cold sore (not specified) and she might touch the tong with it.The reporter mentioned that her dentist prescribed her a mouthwash and not everything is fine, she does not have any redness anymore, she just feels something in the back of her tongue but will check that with the dentist.An event " tongue discomfort" for the verbatim "feels something in the back of her tongue".

• Brand Name: COREGA DENTURE ADHESIVE CREAM
• 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: 11365273
• MDR Text Key: 242297970
• Report Number: 3003721894-2021-00044
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/01/2021

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/23/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR