MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-06-07 for POLIDENT TABLET * manufactured by Glaxosmithkline Consumer Healthcare Med Affairs, Us Product Safety.
[409615]
This case was reported by a consumer and described the occurrence of congestive heart failure in a pt who used polident (polident overnight denture cleanser tablets) to clean their dentures. The consumer initially called to report their non-serious events with polident for partials. A physician or other health care professional has not verified this report. The pt's past medical history included osteoarthritis and a family history of congestive heart failure. Approx 20 years ago, the pt started using polident overnight (dental) and was hospitalized and diagnosed with congestive heart failure. They were hospitalized eight more times during the 20-year period that they used polident. They continue to use polident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00001 |
| MDR Report Key | 592739 |
| Report Source | 04 |
| Date Received | 2004-06-07 |
| Date of Report | 2004-05-28 |
| Date of Event | 1982-01-01 |
| Date Mfgr Received | 2004-05-06 |
| Date Added to Maude | 2005-04-20 |
| 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 TABLET |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2004-06-07 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 582592 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE MED AFFAIRS, US PRODUCT SAFETY |
| Manufacturer Address | 1500 LITTLELTON RD PARSIPPANY NJ 070543884 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 1 | 1. Hospitalization; 2. Other | 2004-06-07 |