MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-11 for MAXCEM ELITE 33872/33874 manufactured by Kerr Corporation.
[5132822]
A dental office alleged that a patient had experienced sores in the mouth, irritation and redness on the gum line after restorative cementation procedures were completed using the maxcem elite clear product.
Patient Sequence No: 1, Text Type: D, B5
[12638837]
The patient had five (5) different crowns placed in the last five (5) years. In 2013, during the patient's last visit, the doctor suggested that the patient seek medical attention with an allergist. It was confirmed with an allergist that the patient is allergic to the maxcem elite product. The doctor reported that he will remove all five (5) restorations and cement them with zinc oxide eugenol based cement. To date, the patient is doing fine. The products alleged in this incident were not returned and no lot number was provided; therefore, no evaluations can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00685 |
| MDR Report Key | 4320949 |
| Report Source | 05 |
| Date Received | 2014-12-11 |
| Date of Report | 2014-11-21 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2014-12-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 WEST 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 | 3 |
| Brand Name | MAXCEM ELITE |
| Generic Name | CEMENT, DENTAL |
| Product Code | MZW |
| Date Received | 2014-12-11 |
| Catalog Number | 33872/33874 |
| Operator | DENTIST |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-12-11 |