MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-06 for DEMI PLUS 910860-1 manufactured by Kerr Corporation.
[4630563]
A doctor alleged that multiple patients had experienced sensitivity after light curing the composite with demi plus. This is the fifth of five (5) reports.
Patient Sequence No: 1, Text Type: D, B5
[12325886]
Specific information with regard to the exact number of patients affected, genders, ages, and weights were not provided by the office. Although the doctor identified two (2) different demi plus units associated with the sensitivity issues, the doctor could not verify which unit was used on any of the patients; therefore, no serial numbers were identified in this report. The units involved in the alleged incident include serial number (b)(4). The doctor re-cured the restoration for each of the patients using a different light, without further incident. To date, each of the patients are doing fine. The devices involved in the alleged incidents have not been returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00535 |
| MDR Report Key | 3984958 |
| Report Source | 05 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-09 |
| Date Mfgr Received | 2014-07-09 |
| Date Added to Maude | 2014-08-06 |
| 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 | MS. 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 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEMI PLUS |
| Generic Name | ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-08-06 |
| Catalog Number | 910860-1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 W COLLINS AVE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-08-06 |