MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER); UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Choking (2464)

Event Type  Injury  

Event Description

Choked because it didn't hold anything [choking].Case description: this case was reported by a consumer via interactive digital media (facebook) and described the occurrence of choking in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number unk, expiry date unknown) for drug use for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser).On an unknown date, an unknown time after starting corega (unspecified denture adhesive or denture cleanser), the patient experienced choking (serious criteria gsk medically significant) and product complaint.The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the choking and product complaint were unknown.The reporter considered the choking to be related to corega (unspecified denture adhesive or denture cleanser).This report is made by gsk/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 a consumer via interactive digital media (facebook) on 13dec2022.It was reported that "first time i used it, i went to eat it and choked because it didn't hold anything.".

Manufacturer Narrative

Argus case id: (b)(4).

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: 184 liberty corner road; suite 200; warren, NJ 07059 ; 8888255249
• MDR Report Key: 16138197
• MDR Text Key: 307093771
• Report Number: 3003721894-2022-00209
• 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: 12/13/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/11/2023
• 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