VENUS DIAMOND FLOW
Received Dec 5, 2013
Report 1925223-2013-00168 · MDR key 3520741
Device
Generic name
Ebc Sealant, Pit And Fissure, And Condi
Manufacturer
Heraeus Kulzer GmbhModel number
BXLCatalog number
660403654
Lot number
010022
Product problems
- Loss of or Failure to Bond
- Shelf Life Exceeded
Patient
Not reported
- Difficulty Chewing
Narrative
Description of Event or Problem
THIS IS THE SECOND OF TWO REPORTS FOR ONE OFFICE USING TWO DIFFERENT DEVICES. A DENTIST PLACED ANTERIOR AND POSTERIOR FILLINGS AND THEY ALL CAME OUT A FEW WEEKS AFTER PLACEMENT. SHE USED IBOUND TE AND VENUS DIAMOND FLOW BXL. SHE ETCHED THE TEETH WITH H2PO 35% FOR 1 MIN, RINSED, LIGHTLY DRIED TO LEAVE SLIGHTLY MOIST. SHE APPLIED THE BONDING AGENT, AND IMMEDIATELY AIR DRIED WITH SHORT GENTLE AIR BLAST, AND THEN CURED FOR 20 SECONDS. DISCUSSED ALLOWING 15 SECONDS OF DWELL TIME AND CHECKING FOR UNIFORM GLOSSINESS. THE LOT NUMBER OF THE VENUS DIAMOND FLOW IS AN EXPIRED LOT NUMBER. SHE PLACED THESE FILLINGS IN OCTOBER AFTER IT HAD EXPIRED. DISCUSSED THAT EFFICACY IS NOT GUARANTEED AFTER THE EXPIRY DATE. SHE HAD TO GET BACK TO A PT SO SHE HAD TO GET OFF THE PHONE. PLEASE REFER MFR REPORT # 9610902-2013-00117.