MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-10 for DEMI PLUS 910860-1 manufactured by Kerr Corporation.
[5693931]
A doctor alleged that four (4) patients restorations did not fully polymerize after light curing with the demi plus. This is the fourth of four (4) reports.
Patient Sequence No: 1, Text Type: D, B5
[13211946]
Specific patient information with regard to age, gender and weight was not provided by the office. The doctor removed the composite and repeated the restoration using a different light, without further incident. To date, the patient is doing fine. The product was not returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2015-00022 |
| MDR Report Key | 4681893 |
| Report Source | 05 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-12 |
| Date Mfgr Received | 2015-03-12 |
| Date Added to Maude | 2015-04-13 |
| 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 | 2015-04-10 |
| 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 | 2015-04-10 |