MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2006-06-20 for POLIDENT DENTURE CLEANSER TABLETS * manufactured by Glaxosmithkline, Rtp Nc.
[15189998]
This case was reported by a consumer, and described the occurence of possible allergy in a female pt who received polident (polident denture cleanser tablets) tablet over a period of years for dental cleaning. A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure. Co-suspect med included polident, ranitidine and diovan hct. Concurrent meds included aspirin. On an unk date, the pt started polident. At an unk time after starting polident, while at a dental appt, the pt was advised that the roof of her mouth was hot and she had developed a rash. Subsequently, treatment with polident discontinued and the events resolved. The pt continued to use polident intermittently, usually prior to dental visits. In 2005, the pt was hospitalized (duration unk) to determine the cause of hives. Since 2005, the pt experienced hives 5 times, usually occurring every 2 to 4 months. Additionally, the pt reported that she developed a cough years ago while using polident. Polident and he told there was no way to test for that. Additionally, the pt stated that she lost her job during this time, which led to her feeling depressed. The pt could not provide product info or lot code because she no longer had the product. Nine mos later polident was reintroduced and she experienced feeling funny and had tingling in her mouth. She stated that the roof of her mouth was dry and itching, she experienced runny nose, coughing and mouth watering. The pt reported that she received treatment with diphendydramine (benadryl), loratadine (claritin), and a week long course of methylprednisolone (medrol) and prednisone. At an unk time later, the events resolved. Five mos later, the pt restarted polident and subsequently broke out in hives. The pt self treated with benadryl. The pt continued to feel "horrible" and visited her physician the same day. She stated that she had swollen hands, an itching throat and runny nose. While at the dr's office, she fainted. Thirty mins prior to the fainting episode, the pt had taken ranitidine (for hives) along with diovan hydrochlorothiazide. According to the pt, her physician thought she that she had become dehydrated and her blood pressure dropped, resulting in syncope. It was unk if the pt sustaiend a head injury during the fall, so she was taken to the hosp via ambulance where she was admitted for a few days. No head injuries were noted upon exam. While in the hosp she was treated with benadryl and claritin and her blood pressure med was changed to diovan 160 mg (with hydrochlorothiazide). The pt underwent many tests (unspecified) and she was discharged on 26 may 2006. Discharge instructions included treatment with cimetidine (generic), medrol, claritin and benadryl. She statted that her dr ruled out aspirin allergy and allergy to blood pressure med. She was given multiple allergy tests and it was determined that she was not "particularly allergic" to any foods. She reported that her dr felt she was allergic to a component of polident and he told her there was no way to test for that. Additionally, the pt stated that she lost her job during this time, which led to her feeling depressed. The pt could not provide product info or lot code because she no longer had the product.
Patient Sequence No: 1, Text Type: D, B5
[15566404]
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 | 1020379-2006-00002 |
| MDR Report Key | 728289 |
| Report Source | 04 |
| Date Received | 2006-06-20 |
| Date of Report | 2006-06-16 |
| Date Mfgr Received | 2006-06-08 |
| Date Added to Maude | 2006-06-26 |
| 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 | 2006-06-20 |
| 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 | 716577 |
| Manufacturer | GLAXOSMITHKLINE, RTP NC |
| Manufacturer Address | * * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-06-20 |