MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-17 for ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTE manufactured by Ultradent Products, Inc. / Oratech Llc.
| Report Number | MW5090472 |
| MDR Report Key | 9208114 |
| Date Received | 2019-10-17 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-05-29 |
| Date Added to Maude | 2019-10-18 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRADENT ULTRACAL XS CALCIUM HYDROXIDE PASTE |
| Generic Name | LINER, CAVITY / CALCIUM HYDROXIDE |
| Product Code | EJK |
| Date Received | 2019-10-17 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS, INC. / ORATECH LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2019-10-17 |