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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  Injury  

Manufacturer Narrative

Argus case id: (b)(4).

Event Description

Eats the food with corega [accidental device ingestion].Case description: this case was reported by a consumer via call center representative and described the occurrence of accidental device ingestion in a 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) 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 gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional information: adverse event information was received via call center representative (e-mail) on 17 mar 2021 and the consumer wrote "to be honest it is good for nothing, eats the food with corega and expensive and ridiculous".

• 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, NC 27709 ; 8888255249
• MDR Report Key: 11664820
• MDR Text Key: 245937826
• Report Number: 3003721894-2021-00108
• 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: 03/17/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/14/2021
• 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