MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-01-13 for POLIGRIP DENTURE ADHESIVE FORMULATION UNKNOWN manufactured by Glaxosmithkline Dungarvan Ltd.
[174667667]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174667669]
Death [unknown cause of death]. Case description: this case was reported by a consumer and described the occurrence of death nos in a female patient who received gsk denture adhesive (formulation unknown) (poligrip denture adhesive formulation unknown) unknown for product used for unknown indication. On an unknown date, the patient started poligrip denture adhesive formulation unknown. On an unknown date, an unknown time after starting poligrip denture adhesive formulation unknown, the patient experienced death nos (serious criteria death and gsk medically significant). On an unknown date, the outcome of the death nos was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death nos to be related to poligrip denture adhesive formulation unknown. Additional details: the patient was a poligrip user. This case was linked with gb2019eme195253 by same reporter, different patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2019-00383 |
| MDR Report Key | 9580318 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-17 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-01-13 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | PO BOX 13398 RESEARCH TRIANGLE PARK |
| Manufacturer City | 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 | POLIGRIP DENTURE ADHESIVE FORMULATION UNKNOWN |
| Generic Name | UNKNOWN |
| Product Code | KOT |
| Date Received | 2020-01-13 |
| 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, WATERFORD, EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-01-13 |