MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,study report with the FDA on 2015-09-18 for TRIPLE SALT DENTAL ADHESIVE CREAM manufactured by Glaxosmithkline Dungarvan Ltd..
[26952686]
Case reported by the corega program. Pt's son mentioned that his mother died (unk cause) on (b)(6) 2015. He did not provide more info and there was no authorization to contact with dentist. The action taken of corega ultra cream was not applicable. Case was considered closed.
Patient Sequence No: 1, Text Type: N, H10
[26952687]
Death nos [unk cause of death]. Case description: this case was reported by a consumer via pt support programs and described the occurrence of unk cause of death in a (b)(6) female pt who received triple salt dental adhesive cream for denture wearer. On an unk date,the pt started triple salt dental adhesive cream. On (b)(6) 2015, an unk time after starting triple sale dental adhesive cream, the pt experienced unk cause of death (serious criteria death and gsk medically significant). On an unk date, the outcome of the unk cause of death was fatal. The subject died on (b)(6) 2015. The reported cause of death was unk cause of death. It was unk if the reporter considered the unk cause of death to be related to triple salt dental adhesive cream.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2015-00010 |
| MDR Report Key | 5107972 |
| Report Source | CONSUMER,FOREIGN,STUDY |
| Date Received | 2015-09-18 |
| Date of Report | 2015-08-20 |
| Date of Event | 2015-08-14 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-09-28 |
| 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 | 8008255249 |
| Manufacturer G1 | GSK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIPLE SALT DENTAL ADHESIVE CREAM |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-09-18 |
| Device Availability | * |
| Device Age | DA |
| 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. Death; 2. Other | 2015-09-18 |