MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2020-03-31 for ULTRA COREGA CREMA SIN SABOR manufactured by Glaxosmithkline Dungarvan Ltd.
[185819101]
Argus case (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185819102]
Unknown cause of death. Case description: this case was reported by a consumer via call center representative and described the occurrence of death in a female patient who received double salt dental adhesive cream (ultra corega crema sin sabor) cream for product used for unknown indication. Co-suspect products included denture cleanser (corega tablets) tablet for product used for unknown indication. On an unknown date, the patient started ultra corega crema sin sabor at an unknown dose and frequency and corega tablets at an unknown dose and frequency. On an unknown date, an unknown time after starting ultra corega crema sin sabor and corega tablets, the patient experienced death (serious criteria death and gsk medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death to be related to ultra corega crema sin sabor and corega tablets. Additional details: it was reported that the patient died about a year and a half ago. The patient two tubes and two bars of like effervescent tablets and trusted the product 100%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003721894-2019-00251 |
| MDR Report Key | 9906930 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2020-03-31 |
| Date of Report | 2019-08-30 |
| Date Mfgr Received | 2019-08-30 |
| Date Added to Maude | 2020-03-31 |
| 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 | ULTRA COREGA CREMA SIN SABOR |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOT |
| Date Received | 2020-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2020-03-31 |