MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-29 for OPTILUX 501 910070 manufactured by Kerr Corporation.
[4809171]
A doctor alleged that a fan blade had separated inside the optilux 501 and had ejected from the back of the unit.
Patient Sequence No: 1, Text Type: D, B5
[12280090]
The incident had occurred upon completion of a patient's procedure. The doctor confirmed that no serious injury was associated with this incident; the broken part did not contact the patient or any employees. A visual and physical evaluation of the returned unit confirmed the complaint. Insufficient adherence of the fan to the fan housing was the root cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00590 |
| MDR Report Key | 4048583 |
| Report Source | 05 |
| Date Received | 2014-08-29 |
| Date of Report | 2014-08-07 |
| Date Mfgr Received | 2014-08-07 |
| Date Added to Maude | 2014-09-15 |
| 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 | 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 | OPTILUX 501 |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-08-29 |
| Catalog Number | 910070 |
| 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 AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-29 |