MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-06-14 for POLIDENT (UNKNOWN) * manufactured by Glaxosmithkline, Consumer Healthcare.
[16477755]
Consumer reported using unspecified polident on their dentures and had a reaction. They described the reaction as an allergic reaction. They described the reaction as itching of the face. They also went into "afib" which was described as an irregular heartbeat. They have had a similar reactions to denture products in the past and the first time they were treated by "shocking their heart twice" and oral medications, coumadin 2. 5 mg daily and toprol xl 25mg daily. They continued the use of the medications and they recovered from the events.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020379-2005-00006 |
| MDR Report Key | 614101 |
| Report Source | 00 |
| Date Received | 2005-06-14 |
| Date Mfgr Received | 2005-06-01 |
| Date Added to Maude | 2005-06-17 |
| 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 RD. |
| 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 (UNKNOWN) |
| Generic Name | DENTAL CLEANSER |
| Product Code | JER |
| Date Received | 2005-06-14 |
| 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 | 603888 |
| Manufacturer | GLAXOSMITHKLINE, CONSUMER HEALTHCARE |
| Manufacturer Address | * PARSIPANY NY * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-06-14 |