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 Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Did not stick [device ineffective].Food that you eat sticks to it.You can drown at any moment [near drowning].Flows and sticks to nasal passage [medication stuck in throat].Case description: this case was reported by a consumer via interactive digital media and described the occurrence of device ineffective in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for drug use 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 device ineffective, near drowning (serious criteria gsk medically significant) and medication stuck in throat.The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the device ineffective, near drowning and medication stuck in throat were unknown.It was unknown if the reporter considered the device ineffective, near drowning and medication stuck in throat 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: this case was received about corega.The reporter comment that the ability of paste was zero and the biggest annoyance was that it flows and sticks to nasal passage and the food that eat sticks to it you can drown at any moment.

Manufacturer Narrative

Argus case (b)(4).

Event Description

Did not stick [product adhesion issue], food that you eat sticks to it.You can drown at any moment [accidental ingestion of product], flows and sticks to nasal passage [medication stuck in throat], the ability of paste is zero [device ineffective].Case description: this case was reported by a consumer via interactive digital media and described the occurrence of device ineffective in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for drug use 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 device ineffective, near drowning (serious criteria gsk medically significant) and medication stuck in throat.The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown.On an unknown date, the outcome of the device ineffective, near drowning and medication stuck in throat were unknown.It was unknown if the reporter considered the device ineffective, near drowning and medication stuck in throat 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: this case was received about corega.The reporter comment that the ability of paste was zero and the biggest annoyance was that it flows and sticks to nasal passage and the food that eat sticks to it you can drown at any moment.This report is being resubmitted to capture corrections.The information was received on 20 jan 2020: event was initially incorrectly coded as near drawing was change to accidental device ingestion and one more event product adhesion issue was added in the case.

• 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: 9664205
• MDR Text Key: 191793664
• Report Number: 3003721894-2020-00026
• 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,Followup
• Report Date: 01/20/2020

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other