inforMED
MalfunctionEHJ

VENUS SUPRA

Received Sep 17, 2013 · Event occurred Aug 8, 2013

Report 1925223-2013-00136 · MDR key 3368374

Device

Generic name

Ehj-abrasive Disk

Catalog number

66039110

Lot number

232529

Product problems

  • Break

Patient

45 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DEALER REP E-MAILED IN THE FOLLOWING: DR (B)(6) IS USING THE SUPRA POLISHING POINTS AND HAD ONE BREAK ON HIS FIRST USE THE OTHER DAY. I HAVE THE BROKEN ONE IF YOU NEED IT. SPOKE TO THE DENTIST. THE POLISHER WAS A SMALL GREY FLAME. IT BROKE ON FIRST USE. HE SAID HE JUST TOUCHED THE TOOTH AND HAD NOT APPLIED PRESSURE WHEN IT SPLIT IN HALF. HE SAID NO ONE WAS INJURED. HE SAID THAT HE HAS USED THE POLISHER FOR 2 YEARS AND HAS NEVER HAD A PROBLEM WITH THEM. REF. MFR # 3005665377-2013-00001.