FDA Adverse Event
Summary report: N
BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE
MDR report key: 4368645
·
Received September 16, 2014
Report
- Report Number
- 9612352-2014-00016
- Date Received
- September 16, 2014
- Date of Event
- August 7, 2014
- Report Date
- September 15, 2014
- Manufacturer
- IVOCLAR VIVADENT, AG
- Product Code
- EBZ
- PMA / PMN Number
- K110756
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
PROBE BROKE IN PT'S MOUTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574052 | BLUEPHASE LIGHT PROBE 10MM BLACK (STYLE | ACTIVATORY, POLYMERIZATION | EBZ | IVOCLAR VIVADENT, AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |