BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILHOUETTE

    MDR report key: 1647151 · Received March 25, 2010

    Report

    Report Number
    MW5015312
    Event Type
    Injury
    Date Received
    March 25, 2010
    Report Date
    March 25, 2010
    Manufacturer
    DENTALEZ GROUP
    Product Code
    NRU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT IN QUESTION HAS AN ONGOING HISTORY FROM THE FIRST YEAR OF PURCHASE/USE -2007 & 2007- TO PRESENT. THE DENTAL EQUIPMENT IS MFG BY DENTALEZ GROUP LOCATED IN (B) (4). THE EQUIPMENT IS CORRODING, RUSTING, PEELING AND BREAKING APART AFTER JUST THREE YEARS OF MODERATE CLINICAL USE. MY CONCERN IS THAT IT IS NOT KNOWN WHETHER THESE MATERIALS ARE SAFE TO MY PTS, STAFF OR MYSELF SINCE I AM NOT FAMILIAR WITH THE REACTION OF THIS EQUIPMENT TO NORMAL CLINICAL USE AS IT FOLLOWS A PATTERN OF UNUSUAL WEAR AND TEAR IN SUCH A SHORT PERIOD TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE DENTALEZ DENTAL CHAIR NRU DENTALEZ GROUP CMU-D 2650F AE 1565
    2 SILHOUETTE DELIVERY UNIT NRU DENTALEZ GROUP CMU. 2431F AE 1653

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability