MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-11-28 for COREGA DENTURE POWDER * manufactured by Glaxosmithkline.
[543713]
This case was reported by a consumer and described the occurrence of worsening of intestine inflammation in a female pt who rec'd corega denture powder over a period of unknown for dentures. A physician or other health care professional has not verified this report. Concurrent medical conditions included inflammation of intestine and pain (unspecified). On an unknown date, the pt started corega denture powder (topical and oral), unknown dosing. At an unknown time after starting corega denture powder, after using the product regularly, the pt experienced worsening of intestine inflammation, exacerbation of pain and wrong route of administration. The pt believed that the events may be due to the powder she swallowed when fixing her dentures. At the time of reporting, the events were worse. This case was assessed as medically serious by gsk. Manufacturer's comment: the manufacturer report number for this case is 9681138-2006-00017. Neither the lot nor the product are available. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2006-00017 |
| MDR Report Key | 791304 |
| Report Source | 04 |
| Date Received | 2006-11-28 |
| Date of Report | 2006-11-28 |
| Date Mfgr Received | 2006-11-09 |
| Date Added to Maude | 2006-12-08 |
| 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 | 0 |
| Manufacturer Street | P O BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 1888825549 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | CLOCKERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVAN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COREGA DENTURE POWDER |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2006-11-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 778941 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * RTP NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-28 |