BEUDAMED
    FDA Adverse Event Other Summary report: N

    49D-1 HANDPIECE

    MDR report key: 416936 · Received August 29, 2002

    Report

    Report Number
    8030962-2002-00001
    Event Type
    Other
    Date Received
    August 29, 2002
    Date of Event
    December 12, 2000
    Report Date
    August 29, 2002
    Manufacturer
    MICRO-MEGA
    Product Code
    EFB
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A DENTIST BURNED AT FIRST DEGREE THE LIP OF A PT WITH A DENTAL HANDPIECE. THE HANDPIECE HAD BEEN CLEANED WITH A PRODUCT NOT COMPLETELY REMOVED AFTER CLEANING. THIS PRODUCT STAYED IN THE HANDPIECE CAUSING A STICKING OF THE MECHANICAL PIECES AND A BAD LUBRICATION. THE CO ADVISED THE USER OF PROPER CLEANING, RINSING AND LUBRICATION PROCESS ACCORDINGLY THE USER'S GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 49D-1 HANDPIECE DENTAL HANDPIECE EFB MICRO-MEGA 50100126 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other