MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2006-08-31 for POLIDENT DENTURE CLEANSER TABLETS * manufactured by Glaxosmithkline.
[503155]
This care was reported by a consumer and described the occurrence of watery diarrhea in a female patient who received polident whitening denture cleanser tablet for dentures. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, caffeine consumption and high blood pressure. Concurrent medications included acebutolo hydrochloride (rhotral), ramipril (altace), and rimantandine hydrochloride (rimantadine). Co-suspect medication included irbesartan (avapro). In 2006, the patient started polident whitening denture cleanser. Previously, the patient received polident 5 minute and/or overnight over a duration of one year without any problems. Within 2 days of starting polident whitening denture cleanser, the patient experienced watery diarrhea, sometimes explosive. She reported that she did not have one formed bowel movement for the 6 weeks she used the product. She aslo experienced mild nausea and cramping along with the diarrhea, but no vomiting. She reported that twice, she did not make it to the bathroom approximately two weeks after the nausea began, the patient visited her physician. Blood tests indicated "slightly elevated liver levels". Stool samples were negative for parasites and bacteria. The physician and patient considered the cause of diarrhea might have been avapro which she then stopped taking. She stop taking any other medications that were thought to have been the cause and the events did not resolve until she switched back to the 5-minute polident. This case was assessed as medically serious by gsk. Treatment with polident whitening denture cleanser was discontiued. At the time of reporting, the events were resolved.
Patient Sequence No: 1, Text Type: D, B5
[7798837]
Mfr's report number for this case is 1020379-2006-00005. Polident is manufactured in another state, and neither the lot number or the product are available for testing. No corrective actions have been required based on this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020379-2006-00005 |
| MDR Report Key | 757797 |
| Report Source | 01,04 |
| Date Received | 2006-08-31 |
| Date of Report | 2006-08-31 |
| Date Mfgr Received | 2006-08-23 |
| Date Added to Maude | 2006-09-08 |
| 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 | PO BOX 13398 |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 8888255249 |
| Manufacturer G1 | MEMPHIS FACILITY |
| Manufacturer Street | 2149 HARBOR AVENUE |
| 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 TABLETS |
| Generic Name | DENTURE CLEANSER |
| Product Code | JER |
| Date Received | 2006-08-31 |
| 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 | 745697 |
| Manufacturer | GLAXOSMITHKLINE |
| Manufacturer Address | * RTP NC * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-08-31 |