BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENUS SUPRA

    MDR report key: 3666830 · Received November 12, 2013

    Report

    Report Number
    1925223-2013-00158
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Report Date
    October 14, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EHJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER WHO HAS USED THE POLISHER FOR SEVERAL YEARS COMPLAINED THAT IT BROKE ON FIRST USE. THE LOT NUMBER IS NOT AVAILABLE AS THE POLISHER WAS STORED AWAY FROM ITS PACKAGING. REFERENCE MFR REPORT 3005665377-2013-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586428 VENUS SUPRA EHJ-ABRASIVE DISK EHJ HERAEUS KULZER GMBH FLAME

    Patients

    Seq Age Sex Outcome Treatment
    1