MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-22 for MAXCEM ELITE manufactured by Kerr Corporation.
[117869065]
No patient information was provided in regards to age, weight, ethnicity, and race. The date of event was reported as being in the last ten months, specific date not provided. Device manufacture date cannot be determined because there was not lot number provided. The product was not returned and there was no lot number or part number provided, therefore no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[117869066]
A complainant alleged that one (1) patient had to get a root canal done after multiple debondings and cementations caused sensitivity.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2018-00001 |
| MDR Report Key | 7805122 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-22 |
| Date of Report | 2018-08-21 |
| Date Mfgr Received | 2018-08-21 |
| Date Added to Maude | 2018-08-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | KAVO KERR |
| 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 | 3 |
| Brand Name | MAXCEM ELITE |
| Generic Name | CEMENT |
| Product Code | EMA |
| Date Received | 2018-08-22 |
| 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; 2. Required No Informationntervention | 2018-08-22 |