BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENUS SUPRA

    MDR report key: 3368374 · Received September 17, 2013

    Report

    Report Number
    1925223-2013-00136
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 22, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EHJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466816 VENUS SUPRA EHJ-ABRASIVE DISK EHJ HERAEUS KULZER GMBH 232529

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR