MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2005-01-05 for POLIDENT TABLETS * manufactured by Glaxosmithkline Consumer Healthcare.
[384720]
This case was reported by a consumer and described the occurrence of a stroke in a pt who used polident denture cleanser tablets for stain dentures. The consumer called with a product question. A physician or other health care professional has not verified this report. The pt's past medical history included smoking. Concurrent medical conditions included arteritis, heartburn and high blood pressure. Concurrent medications included cardizem sr, glyburide, detrol la, pepcid and centrum silver. In 1945 the pt started using polident denture cleanser tablets. In 1991, the pt experienced double vision, light-headedness and collapsed acutely falling down. They were taken to the er and diagnosed with a stroke; pt could not recall the treatmetns. As a consequence the pt walks with a cane and a walker alternatively and has left-sided paralysis. During their 2 week hospitalization the pt was also diagnosed with adult onset diabetes pt could not remember their initial fasting blood treated with insulin; currently their fbs remains steady at 100mg/dl with medication and proper diet. While in the hosp the pt also had their gall bladder removed due to deterioration and gall stones; pt was treated with postoperative analogestic medications. Treatment with polident was continued. The left-sided paralysis, diabetes, cane and wheelchair use are ongoing; all other events have resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00019 |
| MDR Report Key | 564018 |
| Report Source | 04 |
| Date Received | 2005-01-05 |
| Date of Report | 2005-01-05 |
| Date of Event | 1991-01-01 |
| Date Mfgr Received | 2004-12-15 |
| Date Added to Maude | 2005-01-10 |
| 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 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 TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2005-01-05 |
| 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 | 553752 |
| Manufacturer | GLAXOSMITHKLINE CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit | 2005-01-05 |