MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for PREMISE manufactured by Kerr Corporation.
[121703873]
No patient information was provided in regards to weight, ethnicity, and race. No lot number was provided therefore manufactured date cannot be provided. The product was not returned and no lot number was provided; therefore an evaluation was not conducted.
Patient Sequence No: 1, Text Type: N, H10
[121703874]
A complainant alleged that the patient's gums got inflamed and had an allergic reaction including swelling. It was reported that the patient had four fillings done with premise. The dentist prescribed antibiotics, amoxicillin, cortizone and perioguard. Patient was also treated by a periodontist who prescribed hydrogen peroxide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2018-00003 |
| MDR Report Key | 7907945 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-09-25 |
| 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 | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PREMISE |
| Generic Name | TOOTH SHADE RESIN MATERIAL |
| Product Code | EBF |
| Date Received | 2018-09-25 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 W COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-25 |