MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-08-02 for SUPER WERNET'S * manufactured by Glaxosmithkline.
[17437730]
This case was reported by a consumer and described the occurrence of liver metastases coloncarcinoma and lung metastasis in a pt who received super wernet's denture adhesive powder over a period of 7 months for loose dentures. A physician or other health care professional has not verified this report. The pt's part medical history included allergy to novocaine, arthritis, automobile accident, colon cancer, dental removal, drug allergy, esophageal reflux disease, hip degeneration and tooth abscess. Concurrent medications included warfarin, coreg, atacand, norvasc, spironolactone + hydrochlorothiazide, synthroid, detrol la, oxybutyn, protonix, hydrocodone, centrum, coenzyme q-10, baby aspirin, calcium + magnesium + zinc, glucosmaine/chondroitin, and super b complex. In 2003 the pt started super wernet's. In december 2003, the pt was diagnosed with metastatic spread of colon cancer to the lung and liver. Pt also experienced weight loss, decreased white blood cell count and bone pain. This case was assessed as medically serious by gsk. The pt began chemotherapy treatment with oxaliplatin, calcium folinate (leucoverin) fluorouracil (5fu) 26 january 2004 and pegfilgrastium (neulasta) in june 2004. All events are resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681138-2004-00013 |
| MDR Report Key | 538746 |
| Report Source | 04 |
| Date Received | 2004-08-02 |
| Date of Report | 2004-07-29 |
| Date of Event | 2003-12-01 |
| Date Mfgr Received | 2004-06-29 |
| Date Added to Maude | 2004-08-16 |
| 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 | 1500 LITTLETON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE, IRELAND |
| Manufacturer Street | CLOCHERANE, YOUGHAL ROAD |
| Manufacturer City | DUNGARVIN |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER WERNET'S |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-08-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 528016 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 11 | 1. Other | 2004-08-02 |