MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-09-04 for L.E. DEMETRON II 910740-2 manufactured by Kerr Corporation.
[21446934]
Kerr corporation was notified on (b)(6) 2014 that a complainant had alleged that she had sustained certain serious and permanent physical injuries due to exposure from defective l. E. Demetron ii curing lights during the period of (b)(6) 2010 through (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[21737705]
Specific patient information was not provided. It was stated that medical attention had been sought and the complainant had been diagnosed with pterygium in both eyes; however, no further incident information was provided. The devices involved in the alleged incident were not returned and no serial numbers were provided; therefore, no evaluation can be conducted. The root cause of the incident cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00594 |
| MDR Report Key | 4059736 |
| Report Source | 05 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-01-16 |
| Date Mfgr Received | 2014-01-16 |
| Date Added to Maude | 2014-09-04 |
| 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 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 | L.E. DEMETRON II |
| Generic Name | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-09-04 |
| Catalog Number | 910740-2 |
| Operator | DENTIST |
| Device Availability | N |
| 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; 2. Required No Informationntervention | 2014-09-04 |