MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA ULTRA POWDER; DENTURE ADHESIVE

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

Patient Problem Pyrosis/Heartburn (1883)

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Swallow a huge amount of it, accidental device ingestion.I have had enormous heartburn.Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a male patient who received denture adhesive powder-double salt (corega ultra powder) oral powder (batch number unk, expiry date unknown) for product used for unknown indication.On an unknown date, the patient started corega ultra powder.On an unknown date, an unknown time after starting corega ultra powder, the patient experienced accidental device ingestion (serious criteria gsk medically significant and other: gsk medically significant) and heartburn.The action taken with corega ultra powder was unknown.On an unknown date, the outcome of the accidental device ingestion and heartburn were unknown.It was unknown if the reporter considered the accidental device ingestion and heartburn to be related to corega ultra powder.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details : adverse event information was received by a consumer via call center representative (email) on 1(b)(6) 2022.The consumer stated that "i must also point out to you, that for a few months i have had enormous heartburn.I guess it comes from the product, since swallow a huge amount of it, since it's very soft which was not the case before i am currently in treatment, i have had a gastroscopy, i am awaiting the results.".

• Brand Name: COREGA ULTRA POWDER
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan,, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park, 27709 ; 8888255249
• MDR Report Key: 14754039
• MDR Text Key: 294574692
• Report Number: 3003721894-2022-00081
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/11/2022

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?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/21/2022
• 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
• Treatment: 1) NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Sex: Male