MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-29 for DENTEK TEMPARIN manufactured by Us Dentek Corp.
[1631749]
Nausea, dizziness, blurred vision, fast heartbeat, nasty taste in mouth, blank outs, numbness of the face, tingling, headaches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016966 |
| MDR Report Key | 1784826 |
| Date Received | 2010-07-29 |
| Date of Report | 2010-07-29 |
| Date of Event | 2010-07-28 |
| Date Added to Maude | 2010-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTEK TEMPARIN |
| Generic Name | MAX |
| Product Code | EMB |
| Date Received | 2010-07-29 |
| Lot Number | 0607-500271KW.LBL |
| ID Number | 0607-500271 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US DENTEK CORP |
| Manufacturer Address | 1460 CADER LANE PETALUMA CA 94954 US 94954 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-29 |