FDA Adverse Event Injury Summary report: N

VENUS DIAMOND

MDR report key: 3350795 · Received August 27, 2013

Report

Report Number
1925223-2013-00114
Event Type
Injury
Date Received
August 27, 2013
Report Date
July 31, 2013
Manufacturer
HERAEUS KULZER GUMBH
Product Code
EBF
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

SPOKE TO ASSISTANT. SHE SAID THAT THEY HAVE HAD SWELLING OR LIFTING WITH THE ANTERIOR VD COMPOSITES. SHE SAID IT IS ONLY SEEN IN THE CLASS V FILLINGS. ASKED ABOUT BONDING AGENT. SHE SAID THAT THEY USE CLEARFIL SE FOR THE CLASS VS AND SCOTCHBOND FOR ALL OTHER FILLINGS. SHE SAID THAT THE FILLINGS LOOK GOOD IN THE OTHER AREAS OF THE MOUTH. SHE SAID THAT THE DENTIST APPLIES THE CLEARFIL, LETS IT SIT ABOUT 10 SECONDS, GENTLY AIR DRIES ABOUT 10 SECONDS, CURES WITH THE HIGH INTENSITY QUICK CURE LIGHT. SHE SAID HE THEN APPLIES THIN LAYER OF THE VD AND USES HELIOBOND TO SPREAD THE VD AROUND OR IT STICKS TO HIS INSTRUMENT. SHE SAID THE COMPOSITE INSTRUMENTS ARE OLD AND SCRATCHED. SHE SAID HE LIGHT CURES WITH THE HIGH INTENSITY LIGHT. SHE SAID SHE THINKS IT MAY BE HIS TECHNIQUE BUT CAN'T SAY FOR SURE. SHE SAID THE DENTIST THINKS IT'S THE VD. SHE SAID THIS HAS BEEN HAPPENING FOR A BOUT A YEAR AND THEY HAVE REPLACED MULTIPLE ANTERIOR FILLINGS. SHE SAID SHE DID NOT REMEMBER WHICH PTS OR HAVE SHADE OR LOT INFO FOR THESE REPLACEMENTS. SHE SAID THAT THESE FILLINGS WERE PLACED ON BRUXISM PTS. DISCUSSED DDS USING PLASMA COATED OR NEW COMPOSITE INSTRUMENTS AND DISCONTINUING USE OF HELIOBOND FOR STICKING. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
417981 VENUS DIAMOND EBF MATERIAL, TOOTH SHADE, RESIN EBF HERAEUS KULZER GUMBH

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention