MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-30 for ULTRACAL manufactured by Ultradent Products Inc..
[61441001]
Patient had lower incisor tooth injected with ultracal (ca(oh)2 injection system. The medicament embolized into vessels around the tooth. Numbness of chin pain , loosening of at least 7 teeth occurred. Likely tooth and even jaw bone loss will occur. This delivery system has no instructions to treat this problem nor a warning about this complication! The manufacturer ultradent in (b)(4) has been notified by me. I am only the surgical consultant and am seeing this problem 5 weeks after occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066469 |
| MDR Report Key | 6140868 |
| Date Received | 2016-11-30 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-10-27 |
| Date Added to Maude | 2016-12-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRACAL |
| Generic Name | CLINER, CAVITY |
| Product Code | EJK |
| Date Received | 2016-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-11-30 |