MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2004-11-02 for POLIDENT * manufactured by Glaxosmitkline.
[19144952]
This case was reported by a consumer and described the occurrence of leg fracture in a pt who received polident (poliment overnight denture cleanser tablets) for dental cleaning. The consumer initially called with a product use question. A physician or other heath care professional has not verified this report. Concurrent medical conditions included allergy to tagamet, diabetes, hypertension, penicillin allergy and sulfa allergy. Concurrent medications included diovan, norvasc and monopril. On an unk date, the pt started polident (dental). In 2003, the pt fell and fractured their leg; they were hospitalized and underwent knee repair surgery in nov 2004. Treatment with polident was continued. The events resolved. Mfr's comment polident is manufactured in memphis, tennessee and neither the product nor lot number of for this product is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2004-00007 |
| MDR Report Key | 553816 |
| Report Source | 04 |
| Date Received | 2004-11-02 |
| Date of Report | 2004-11-01 |
| Date of Event | 2003-11-03 |
| Date Mfgr Received | 2004-10-21 |
| Date Added to Maude | 2004-11-09 |
| 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 | 2004-11-02 |
| 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 | 543449 |
| Manufacturer | GLAXOSMITKLINE |
| Manufacturer Address | * PARSIPPANY NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-11-02 |