MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-06-04 for COREGA ULTRA CREAM WITHOUT FLAVOR manufactured by Glaxosmithkline Dungarvan Ltd..
[20145833]
Hospitalization (due to heart surgery). Case description: this case was reported by a consumer via patient support programs and described the occurrence of hospitalization in a (b)(6) male patient who received triple salt dental adhesive cream (corega ultra cream without flavor) cream (batch number (b)(4), expiry date 02/28/2017) for dental prosthesis wearer. Concurrent medical conditions included cardiac operation. On an unknown date, the patient started corega ultra cream without flavor. On an unknown date, an unknown time after starting corega ultra cream without flavor, the patient experienced hospitalization (serious criteria hospitalization and gsk medically significant). On an unknown date, the outcome of the hospitalization was unknown. The reporter considered the hospitalization to be unrelated to corega ultra cream without flavor. Additional information included: this case reported by distributor. The patient was on corega adhesive cream due to oral prosthesis fixation. The niece's reported that patient was hospitalized (due to heart surgery) and continues to use product. She did not give more information and there was authorization to contact physician. This case was considered closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2015-00016 |
| MDR Report Key | 4862980 |
| Report Source | 01,04 |
| Date Received | 2015-06-04 |
| Date of Report | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Date Added to Maude | 2015-06-24 |
| 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 ULTRA CREAM WITHOUT FLAVOR |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOL |
| Date Received | 2015-06-04 |
| Lot Number | P14063 |
| Device Expiration Date | 2017-02-28 |
| 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. Hospitalization; 2. Other | 2015-06-04 |