inforMED
InjuryEBC

VENUS DIAMOND FLOW SYR

Received Sep 10, 2013

Report 1925223-2013-00133 · MDR key 3353230

Device

Generic name

Ebc Sealant, Pit And Fissure, And Condi

Model number

A2

Catalog number

66040355

Lot number

010106

Product problems

  • Use of Device Problem

Patient

Not reported

  • Sensitivity of Teeth

Narrative

Description of Event or Problem

THIS IS THE THIRD OF FOUR REPORTS FOR ONE OFFICE. SPOKE TO DENTAL ASSISTANT. SHE SAID THAT THEY NOTICED AIR BUBBLES WHILE EXTRUDING. SHE SAID THAT ABOUT FOUR PTS HAVE RETURNED DUE TO SENSITIVITY AND THEY REPLACED THE RESTORATIONS. TWO FOR THE SHADE A1 AND TWO FOR SHADE A2. SHE SAID THAT THE SENSITIVITY RESOLVED AND THEY ARE DOING FINE. SHE SAID THAT THEY CURE THE VDF FOR 20 SECONDS MINIMUM WITH AN LED CURING LIGHT. PLEASE REFER MFR REPORT # 9610902-2013-00096.