MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-06-25 for COREGA DENTURE ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd..
[6258519]
Death nos [death unexplained]. Case description: this case was reported by a consumer via other (distributor) and described the occurrence of death nos in a (b)(6) pt who received gsk denture adhesive (formulation unk) (corega denture adhesive cream) cream (batch number (b)(4), expiry date unk) for denture wearer. On an unk date, the pt started corega denture adhesive cream. On an unk date, an unk time after starting corega denture adhesive cream, the pt experienced death nos (serious criteria death and gsk medically significant). On an unk date, the outcome of the death nos was fatal. It was unk if the reporter considered the death nos to be related to corega denture adhesive cream. This report is made by gsk without prejudice and does not imply any admission or liability for the incident or its consequences. Case comment: this case was reported by a distributor. The pt used corega adhesive cream for prosthesis fixation. The pt's relative reported that the pt died (unk cause). She did not give more info, and there is no authorization to contact the pt's physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2015-00029 |
| MDR Report Key | 4870591 |
| Report Source | 01,04 |
| Date Received | 2015-06-25 |
| Date of Report | 2014-09-30 |
| Date Mfgr Received | 2014-09-30 |
| Date Added to Maude | 2015-06-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA DENTURE ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-06-25 |
| Lot Number | P14063 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GLAXOSMITHKLINE DUNGARVAN LTD. |
| Manufacturer Address | DUNGARVAN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2015-06-25 |