MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-29 for DEMI PLUS 910860-1 manufactured by Kerr Corporation.
[4430658]
A doctor alleged that four (4) patients had experienced sensitivity after light curing the composite with demi plus. This is the second of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5
[11830816]
Specific patient information with regard to age, gender and weight was not provided by the office. The doctor re-cured the restoration using a different light, without further incident. To date, the patient is doing fine. A device evaluation is anticipated but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2014-00272 |
| MDR Report Key | 3778070 |
| Report Source | 05 |
| Date Received | 2014-04-29 |
| Date of Report | 2014-04-01 |
| Date Mfgr Received | 2014-04-01 |
| Date Added to Maude | 2014-04-29 |
| 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 | 2014-04-29 |
| Catalog Number | 910860-1 |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-04-29 |