BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER CART

    MDR report key: 133706 · Received November 20, 1997

    Report

    Report Number
    2016150-1997-00002
    Event Type
    Malfunction
    Date Received
    November 20, 1997
    Date of Event
    September 1, 1997
    Report Date
    September 1, 1997
    Manufacturer
    EIE/ANALYTIC DIVISION OF ORMCO CORP.
    Product Code
    EIA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED VIA THE DENTIST WHO REPORTED THAT PRIOR TO USING THE POWER CART, SHE NOTED THAT THE SLOW SPEED HANDPIECE, AN ACCESSORY TO THE POWER CART, WAS OVER HEATING AND SMOKE WAS BEING EMITTED FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER CART DENTAL OPERATIVE UNIT EIA EIE/ANALYTIC DIVISION OF ORMCO CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *