MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-09-07 for POLIDENT * manufactured by Glexosmithkline.
[363394]
This case was reported by a consumer and described the occurrence of recurrent congestive heart failure in a pt who received polident tablet for dentures. They called regarding a product packaging complaint. A physician or other health care professional has not verified this report. The pt's past medical history included congestive heart failure, heart attack, hypertension, penicillin allergy, sulfa allergy and tylenol #3 allergy. Concurrent medications included lasix. Over 10 years ago, the pt started polident (dental). They reported being hospitlaized 100 to 110 times over the last 10 years for recurrent congestive heart failure. In 1997, they underwent "radical heart surgery" for an unspecified heart valve problem. They were treated with warfarin sodium (coumadin). In 2002, they were told they had early cataract and in 2003 experienced decreased vision and has been treated with an eye wash. In 2004, they were diagnosed with new onset diabetes and treated with metformin hydrochloride (glucophage). Treatment with polident continued. The events are unresolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00004 |
| MDR Report Key | 543314 |
| Report Source | 04 |
| Date Received | 2004-09-07 |
| Date of Report | 2004-09-01 |
| Date Mfgr Received | 2004-08-30 |
| 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 | 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 |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2004-09-07 |
| 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 | * |
| Device Sequence No | 1 |
| Device Event Key | 532689 |
| Manufacturer | GLEXOSMITHKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-09-07 |