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 DENTURE CLEANSER TABLET * manufactured by Glaxosmithkline, Us Product Safety.
[313870]
This case was reported by a consumer and described the occurrence of difficulty writing in a pt who used polident (polident denture cleanser tablets) for dental care. A physician or other health care professional has not verified this report. Concurrent medications included polident overnight denture cleanser tablets. In 2002 the pt started using polident (dental). In 2002, the pt experienced difficulty writing, neurological problems, slurred speech, instability and dizziness. This case was assessed as medically serious by gsk. Treatment with polident was continued. The events are unresolved. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00017 |
| MDR Report Key | 564025 |
| Report Source | 04 |
| Date Received | 2005-01-05 |
| Date of Report | 2005-01-04 |
| Date of Event | 2002-01-01 |
| Date Mfgr Received | 2004-12-09 |
| 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 DENTURE CLEANSER TABLET |
| 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 | 553759 |
| Manufacturer | GLAXOSMITHKLINE, US PRODUCT SAFETY |
| Manufacturer Address | * PARSIPPANY NJ 07054 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-01-05 |