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

Device Problem Product Quality Problem (1506)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(6).

Event Description

Just eating [accidental device ingestion] case description: this case was reported by a consumer via (facebook) interactive digital media and described the occurrence of accidental device ingestion in a female patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number unk, expiry date unknown) for product used 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 accidental device ingestion (serious criteria haleon 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 accidental device ingestion and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega (unspecified denture adhesive or denture cleanser).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 received from a consumer via (facebook) interactive digital media on 22nov2023.The consumer reported that, "the truth is, just eating becomes a gum".The suspect product was reported as corega - unknown variant and size.

• 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: 18324264
• MDR Text Key: 330480107
• Report Number: 3003721894-2023-00205
• 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: 11/22/2023

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: 11/22/2023
• Initial Date FDA Received: 12/14/2023
• 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
• Patient Sex: Female