MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-12 for COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER) manufactured by Glaxosmithkline Dungarvan Ltd.
[185975463]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185975464]
Stomach cancer [gastric cancer]. Case description: this case was reported by a consumer via (b)(6) interactive digital media and described the occurrence of gastric cancer in a patient who received corega (corega (unspecified denture adhesive or denture cleanser)) unknown for product used 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 gastric cancer (serious criteria gsk medically significant). The action taken with corega (unspecified denture adhesive or denture cleanser) was unknown. On an unknown date, the outcome of the gastric cancer was unknown. It was unknown if the reporter considered the gastric cancer 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: patient posted on social media as corega stomach cancer. The verbatim was translated from original post exactly as reported. Event was captured conservatively from the post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2020-00049 |
| MDR Report Key | 9825448 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-15 |
| Date Mfgr Received | 2020-02-15 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA (UNSPECIFIED DENTURE ADHESIVE OR DENTURE CLEANSER) |
| Generic Name | UNKNOWN |
| Product Code | KOT |
| Date Received | 2020-03-12 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD |
| Manufacturer Address | DUNGARVAN, WATERFORD EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |