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

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

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

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

What's left of this disgrace goes to the stomach [accidental device ingestion] causes a lot of illness [illness].Case description: this case was reported by a consumer via interactive digital media (facebook) and described the occurrence of accidental device ingestion in a male patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown (batch number unk, expiry date unknown) for product used for unknown indication.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 gsk medically significant) and illness.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 illness were unknown.It was unknown if the reporter considered the accidental device ingestion to be related to corega (unspecified denture adhesive or denture cleanser).The reporter considered the illness to be related to corega (unspecified denture adhesive or denture cleanser).This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received from a consumer via interactive digital media (facebook) on 30sep2021.The consumer stated that "what's left of this disgrace goes to the stomach and causes a lot of illness.".

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 12646550
• MDR Text Key: 276855685
• Report Number: 3003721894-2021-00345
• 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: 09/30/2021

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: 09/30/2021
• Initial Date FDA Received: 10/18/2021
• 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