MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-10 for DEMI 910770 manufactured by Kerr Corporation.
[5074063]
A doctor's office alleged that the demi light was not curing restorations for two (2) patients. This is the second of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[12465239]
It was reported that the doctor noticed the composite was not fully curing during the patient's procedure. The doctor cured the composite longer, without further incident. No injuries were associated with this incident. To date, the patient is doing fine. This incident is mdr reportable as a malfunction because the device could cause or contribute to a serious injury if the malfunction would to recur. The product has not been returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00660 |
| MDR Report Key | 4240852 |
| Report Source | 05 |
| Date Received | 2014-11-10 |
| Date of Report | 2014-10-24 |
| Date Mfgr Received | 2014-10-24 |
| Date Added to Maude | 2014-11-21 |
| 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 | 7145167623 |
| Manufacturer G1 | KERR CORPORATION |
| Manufacturer Street | 1717 WEST COLLINS AVE. |
| 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 | DEMI |
| Generic Name | ACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-11-10 |
| Catalog Number | 910770 |
| Operator | DENTIST |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 WEST COLLINS AVE. ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-11-10 |