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 910770 manufactured by Kerr Corporation.
[15123314]
A doctor's office alleged that upon removal of the light guide, the demi curing light had shocked the doctor.
Patient Sequence No: 1, Text Type: D, B5
[15292121]
The doctor unplugged the unit and returned it for evaluation. No serious injury was associated with this incident. No medical attention or prescription medication was required. To date, the doctor is doing fine. A visual and physical evaluation was performed on the returned device. It was discovered that the unit had power, but the switch would not turn on the curing light. The incident which occurred could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00554 |
| MDR Report Key | 3984940 |
| Report Source | 05 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-07 |
| Date Mfgr Received | 2014-07-07 |
| Date Added to Maude | 2014-08-15 |
| 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 | 2014-08-06 |
| Catalog Number | 910770 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-08-06 |