MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-23 for DEMI 910770 manufactured by Kerr Corporation.
[15884659]
Although the doctor had identified two (2) demi lights associated with the red welts, she could not verify which serial number was used on the patient; therefore, no serial numbers were identified in this report. The serial numbers of the lights involved in the alleged incident included serial numbers (b)(4). The patient had experienced a red welt on the left side of her lip after a restoration was light cured for twenty (20) seconds. The doctor provided neosporin and mederma to the patient for treatment. The doctor reported that the patient was doing fine at this time; however, the patient did not use the provided mederma medication until approximately one (1) week after the injury had occurred. For this reason, the patient has some hyperpigmentation present at the site of the injury on the left side of her mouth. The device involved in the alleged incident has not been returned; therefore, no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[15933838]
A doctor alleged that three (3) patients had experienced a red welt on the side of their lip after the doctor had light cured restorations using the demi curing light. This is the first of three (3) reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2014-00292 |
| MDR Report Key | 3830571 |
| Report Source | 05 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-04-29 |
| Date Mfgr Received | 2014-04-29 |
| Date Added to Maude | 2014-05-23 |
| 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 | 7145167623 |
| 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 | DEMI |
| Generic Name | ACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION |
| Product Code | EBZ |
| Date Received | 2014-05-23 |
| Catalog Number | 910770 |
| 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 | 2014-05-23 |