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

Lot Number UNKNWON

Device Problem Product Quality Problem (1506)

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

Event Type  Injury  

Manufacturer Narrative

Argus case (b)(4).

Event Description

You consume it and who knows what effect it has on the stomach [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 male patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used for unknown indication.This case was associated with a product complaint.On an unknown date, the patient started corega (unspecified denture adhesive or denture cleanser) at an unknown dose and frequency.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).Additional information: patient used it and it did not last half an hour and it was also released, the product falls apart.When consume it and who knows what effect it has on the stomach, pure scam.

• 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: 11032445
• MDR Text Key: 226650677
• Report Number: 3003721894-2020-00356
• Device Sequence Number: 1
• Product Code: KOT
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2020

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: Lay User/Patient
• Device Lot Number: UNKNWON
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/17/2020
• 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