MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-10-11 for TEMPARIN NI manufactured by Us Dentek Corp.
[211486]
Consumer used this temporary dental filling and experienced excelerated heartbeat and nausea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4003150 |
| MDR Report Key | 364322 |
| Date Received | 2001-10-11 |
| Date of Report | 2001-10-11 |
| Date of Event | 2001-08-13 |
| Date Added to Maude | 2001-12-10 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPARIN |
| Generic Name | TEMPORARY DENTAL FILLING |
| Product Code | EMB |
| Date Received | 2001-10-11 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | GF10,000 1304A |
| ID Number | 2 GRAM BOX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 353429 |
| Manufacturer | US DENTEK CORP |
| Manufacturer Address | 1460 CADER LANE PETALUMA CA 94954 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-10-11 |