FDA Adverse Event
Injury
Summary report: N
DEMIULTRA
MDR report key: 3732037
·
Received April 7, 2014
Report
- Report Number
- 2024312-2014-00187
- Event Type
- Injury
- Date Received
- April 7, 2014
- Report Date
- March 10, 2014
- Manufacturer
- KERR CORPORATION
- Product Code
- EBZ
- PMA / PMN Number
- K123468
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR REPLACED THE FILLING FOR THE PATIENT USING A DIFFERENT LIGHT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN.
Description of Event or Problem · 1
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 SECOND OF THREE (3) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206880 | DEMIULTRA | ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION | EBZ | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | MAJESTIC FLOWABLE PEDO 2 |