MAUDE Adverse Event Report: GLAXOSMITHKLINE DUNGARVAN LTD COREGA EXTRA STRONG; DENTURE ADHESIVE

Lot Number AM6

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

Patient Problem Cancer (3262)

Event Type  Injury  

Manufacturer Narrative

Argus case: (b)(4).

Event Description

Stomach cancer [gastric cancer].Cancer spreading to the esophagus [malignant neoplasm progression].Cancer spreading to the esophagus [esophageal cancer].Case description: this case was reported by a consumer via call center representative and described the occurrence of gastric cancer in a (b)(6) year-old male patient who received double salt dental adhesive cream (corega extra strong) cream (batch number am6, expiry date january 2024) for product used for unknown indication.On an unknown date, the patient started corega extra strong.On an unknown date, an unknown time after starting corega extra strong, the patient experienced gastric cancer (serious criteria gsk medically significant and other: gsk medically significant), malignant neoplasm progression (serious criteria gsk medically significant and other: gsk medically significant) and esophageal cancer (serious criteria gsk medically significant and other: gsk medically significant).The action taken with corega extra strong was unknown.On an unknown date, the outcome of the gastric cancer, malignant neoplasm progression and esophageal cancer were unknown.The reporter considered the gastric cancer, malignant neoplasm progression and esophageal cancer to be related to corega extra strong.This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences.Additional details: the adverse event information was received via call center representative (phone) on (b)(6) 2021.The consumer reported that "the consumer said that from corega extra strong adhesive cream 70 g he developed stomach cancer spreading to the esophagus.He has been using the cream according to the instructions for about 11 years, he said that the doctors warned him at the start, but he did not believe it.Primary batch am6, expiration date jan-2024.He provided his age.He said that the cream is horrid.He asked for the address of the head office.When i wanted to provide it, he said that he would find it himself.He asked if there were other similar complaints.I responded that this information was confidential.He said that he sent the case to his lawyers.I provided the application number.".

• Brand Name: COREGA EXTRA STRONG
• Type of Device: DENTURE ADHESIVE
• Manufacturer (Section D): GLAXOSMITHKLINE DUNGARVAN LTD; dungarvan, waterford ; EI
• MDR Report Key: 12665112
• MDR Text Key: 277385876
• Report Number: 3003721894-2021-00352
• 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: 10/08/2021

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
• Device Lot Number: AM6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 10/20/2021
• 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
• Treatment: NO THERAPY (NO THERAPY)
• Patient Outcome(s): Other
• Patient Age: 58 YR