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

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

Patient Problem Choking (2464)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

I choked and thought it was going down my throat [choking].It started to make me nauseous [nausea].Case description: this case was reported by a consumer via call center representative and described the occurrence of choking in a 70-year-old male patient who received double salt dental adhesive cream (corega cream mint flavor) cream (batch number unk, expiry date unknown) for denture failure.On (b)(6) 2024, the patient started corega cream mint flavor.On (b)(6) 2024, an unknown time after starting corega cream mint flavor, the patient experienced nausea.On an unknown date, the patient experienced choking (serious criteria haleon medically significant).On an unknown date, the outcome of the choking was unknown and the outcome of the nausea was recovered/resolved.The reporter considered the choking and nausea to be related to corega cream mint flavor.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 the consumer via call center representative (phone) on (b)(6) 2024.Reporter stated that "i have to wear a lower prosthesis and i bought corega and i didn't fit in.I put it in as it said on the package and it started to make me nauseous.The dentist told me to only use the corega tape, but i don't think so.I used the 40g corega mint, i'll ask my wife to check the batch.The batch she thinks is 2rtm or 2rtw is very bad.I used the product on (b)(6) 2024, it made me nauseous the same day and i stopped using it.I choked and thought it was going down my throat and stopped using it.I went to the dentist and stopped using it." the suspect product was reported as corega menta creme bico dosador 40g.The action taken was reported as withdrawn with de-challenge as positive and re-challenge as not applicable.

• Brand Name: COREGA CREAM MINT FLAVOR
• 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: 18823913
• MDR Text Key: 336733164
• Report Number: 3003721894-2024-00027
• 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: 02/20/2024

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/04/2024
• 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: 70 YR
• Patient Sex: Male