MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-12-13 for POLIDENT OVERNIGHT TABLET * manufactured by Glaxosmithkline Consumer Healthcare.
[312951]
This case was reported by a consumer's spouse and described the occurrence of prostate cancer in a pt who used polident (polident overnight denture cleanser tablets) for dental cleaning. The consumer's spouse contacted the mfr regarding a product quality complaint. A physician or other health care professional has not verified this report. On an unk date, about ten years ago, the pt started using polident (dental). In 2001, the pt experienced difficulty urinating and was subsequently diagnosed with prostate cancer. The pt was treated with various prostate medications (unspecified) and two cancer chemotherapy treatments, which they did not tolerate well. Treatment with polident was continued. The pt died in 2004 due to the prostate cancer. An autopsy was not performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00015 |
| MDR Report Key | 559881 |
| Report Source | 04 |
| Date Received | 2004-12-13 |
| Date of Report | 2004-12-08 |
| Date of Event | 2001-01-01 |
| Date Mfgr Received | 2004-11-16 |
| Date Added to Maude | 2004-12-17 |
| 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 | MEMPHIS FACILITY |
| Manufacturer Street | 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 OVERNIGHT TABLET |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2004-12-13 |
| 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 | 549581 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2004-12-13 |