MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-02 for POLIGRIP * manufactured by Glaxosmithkline.
[362950]
This case was reported by a consumer and described the occurrence of colon cancer in pt who received poligrip (super poligrip original denture adhesive cream) for dentures. The consumer called to report a product complaint. A physician or other health care professional has not verified this report. The pt's past medical history included hypertension and hypothyroidism. Co-suspect medication included fixodent and denture adhesive. Concurrent medications included synthroid and norvasc. In 1980 the pt started poligrip (dental). In 1981, the pt was diagnosed with colon cancer and treated with chemotherapy and radiation. In the later 1990s, they were hospialized for 5 months for appetite lost and weight loss, the treatment is unk, no etioloty was found and after discharge the events resolved. In 2000, they were diagnosed with prostate cancer, treated with leuprorelin acetate (lupron) and now has bladder problems. Treatment with poligrip was continued. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2650037-2004-00002 |
| MDR Report Key | 543291 |
| Report Source | 04 |
| Date Received | 2004-09-02 |
| Date of Report | 2004-09-02 |
| Date of Event | 1981-01-01 |
| Date Mfgr Received | 2004-08-04 |
| Date Added to Maude | 2004-09-15 |
| 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 | DENTCO FACILITY |
| Manufacturer Street | PR STATE ROAD #3 KILOMETER 76.9 |
| Manufacturer City | HUMACAO PR 00791 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00791 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIGRIP |
| Generic Name | DENTURE ADHESIVE |
| Product Code | KOP |
| Date Received | 2004-09-02 |
| 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 | 532666 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2004-09-02 |