MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-02 for POLIDENT TABLET * manufactured by Glaxosmithkline, Consumer Healthcare.
[344124]
A consumer's neighbor described the occurrence of bone cancer in a pt who used polident (polident denture cleanser tablets) for dental cleaning. The consumer's neighbor contacted the mfr to praise the product. A physician or other health care professional has not verified this report. Concurrent medications included polident overnight denture cleanser tablets. On an unk date, the pt started polident (dental), at an unk dosing. At an unk time after starting polident, the pt fell and was diagnosed with bone cancer. The pt was treated with cancer chemotherapy. The pt was hospitalized some time in 2004, had continued to use polident and died in 9/2004. The cause of death is unk. It is unk whether an autopsy was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00012 |
| MDR Report Key | 557612 |
| Report Source | 04 |
| Date Received | 2004-12-02 |
| Date of Report | 2004-11-18 |
| Date Mfgr Received | 2004-11-08 |
| Device Manufacturer Date | 2003-09-01 |
| Date Added to Maude | 2004-12-06 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1500 LITTLETON RD. |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9738892494 |
| Manufacturer G1 | GLAXOSMITHKLINE |
| Manufacturer Street | MEMPHIS FACILITY 2149 HARBOR AVE. |
| Manufacturer City | MEMPHIS TN 36113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLIDENT TABLET |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2004-12-02 |
| 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 | 547280 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANNY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization | 2004-12-02 |