MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-07 for DEIMULTRA 35664 manufactured by Kerr Corporation.
[16059315]
A doctor alleged that three (3) patients' fillings had cracked or fallen out after it was light cured with the demi ultra. This is the first of three (3) reports.
Patient Sequence No: 1, Text Type: D, B5
[16383776]
The doctor replaced three (3) fillings for the patient using a different light. Upon the patient return visit on (b)(6) 2014, all three (3) fillings were intact; however, one of the teeth had abscessed. The doctor will extract the tooth for the patient. 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 | 2024312-2014-00186 |
| MDR Report Key | 3732040 |
| Report Source | 05 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-03-10 |
| Date of Event | 2013-11-12 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-04-07 |
| 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 | DEIMULTRA |
| Generic Name | ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-04-07 |
| Catalog Number | 35664 |
| 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 | 2014-04-07 |