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