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

Device Problem Product Quality Problem (1506)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

Ends up going to the stomach [accidental device ingestion].The stomach and causes a strong sensation of burning [stomach burning sensation of].Case description: this case was reported by a consumer via (b)(6) interactive digital media 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 denture wearer.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 gsk medically significant), stomach burning sensation of 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, stomach burning sensation of and product complaint were unknown.It was unknown if the reporter considered the accidental device ingestion and stomach burning sensation of 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 information: adverse event information was received on 01 jun 2021 from a consumer via (b)(6), interactive digital media.Consumer reported that "in addition to releasing with hot liquid it ends up going to the stomach and causes a strong burning." pqc information: name of product quality complaint: (b)(4), level 2 reason code: performance complaint level 3 reason code: product does not hold - cpe dnt hold, pqc status: awaiting triage, type of relationship to hsi: related to an hsi with an ae - reported side effects.Follow-up information was received on 02 jun 2021 by quality assurance department for complaint number (b)(4) for unknown lot number and expiry date).Investigator evaluation included: without correct batch or sample number information it is not possible identify the manufacturer site responsible for the claimed product.Based on the investigation performed by the site, the complaint is found to be inconclusive.

• Brand Name: COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER)
• Type of Device: UNKNOWN
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• Manufacturer Contact: po box 13398; research triangle park; 8888255249
• MDR Report Key: 12020994
• MDR Text Key: 267900365
• Report Number: 3003721894-2021-00210
• 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: 06/01/2021

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: 06/01/2021
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No
• 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