MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-06-29 for COREGA ULTRA CREAM WITHOUT FLAVOR manufactured by Glaxosmithkline Dungarvan Ltd.
[6060682]
Hospitalization (unknown cause) [hospitalization]. Case description: this case was reported by a consumer via other (distributor) and described the occurrence of hospitalization (unknown cause) in a (b)(6)-year-old female patient who received triple salt dental adhesive cream (corega ultra cream without flavor) cream for denture wearer. 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 (unknown cause) (serious criteria hospitalization and gsk medically significant). On an unknown date, the outcome of the hospitalization (unknown cause) was unknown. It was unknown if the reporter considered the hospitalization (unknown cause) to be related to corega ultra cream without flavor. The patient's niece reported (via distributor) that her aunt was hospitalized (unknown cause). No further information was provided. Argus case number (b)(4) is a duplicate of (b)(4). All future correspondence will be submitted to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2015-00034 |
| MDR Report Key | 4877412 |
| Report Source | 01,04 |
| Date Received | 2015-06-29 |
| Date of Report | 2014-10-02 |
| Date Mfgr Received | 2014-10-02 |
| Date Added to Maude | 2015-07-01 |
| 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 | 2015-06-29 |
| Lot Number | P14063 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-06-29 |