FDA Adverse Event
Injury
Summary report: N
DEIMULTRA
MDR report key: 3732040
·
Received April 7, 2014
Report
- Report Number
- 2024312-2014-00186
- Event Type
- Injury
- Date Received
- April 7, 2014
- Date of Event
- November 12, 2013
- 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 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.
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 FIRST OF THREE (3) REPORTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 206901 | DEIMULTRA | ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION | EBZ | KERR CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Other| R | MAJESTIC FLOWABLE PEDO 2 |