MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-15 for ULTRACAL XS 1027 manufactured by Ultradent Products Inc.
[97280575]
Retains of lot bb5b2 were tested and found the product to meet specifications. Expressing through the apex during root canal therapy can happen. Reported due to the fact the patient was given medisterol, (steroid pack) to reduce inflamation, this is reportable per 21 cfr 803. Patient started the steroid and was monitored. Ultracal will resorb over time. In house clinican suggested to bring patient back for an xray in 7-10 days.
Patient Sequence No: 1, Text Type: N, H10
[97280576]
Dr stated he expressed some ultracal passed the apex of the tooth #29. He proceeded to finish the root canal therapy. It appeared that the ultracal may have violated the inferior avelar nerve space. The patient is reported a burning sensation in the corner of his mouth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1718912-2017-00041 |
| MDR Report Key | 7191190 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-01-15 |
| Date of Report | 2017-12-21 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2016-10-21 |
| Device Manufacturer Date | 2015-10-28 |
| Date Added to Maude | 2018-01-15 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RONA MURPHY |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8015534200 |
| Manufacturer G1 | ULTRADENT PRODUCTS INC |
| Manufacturer Street | 505 WEST 10200 SOUTH |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84095 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRACAL XS |
| Generic Name | CALCIUM HYDROXIDE CAVITY LINER |
| Product Code | EJK |
| Date Received | 2018-01-15 |
| Catalog Number | 1027 |
| Lot Number | BB5B2 |
| Device Expiration Date | 2016-10-26 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRADENT PRODUCTS INC |
| Manufacturer Address | 505 WEST 10200 SOUTH SOUTH JORDAN UT 84095 US 84095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-01-15 |