BEUDAMED
    FDA Adverse Event Other Summary report: N

    57E2 HANDPIECE

    MDR report key: 416932 · Received August 29, 2002

    Report

    Report Number
    8030962-2002-00002
    Event Type
    Other
    Date Received
    August 29, 2002
    Date of Event
    February 8, 2001
    Report Date
    August 29, 2002
    Manufacturer
    MICRO-MEGA
    Product Code
    EFB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A DENTIST BURNED FIRST DEGREE THE LIP OF A PT WITH A DENTAL HANDPIECE. THE HANDPIECE WAS IN A VERY BAD STATE OF MAINTENANCE AND UNUSABLE FOR A LONG TIME. THE LAST MAINTENANCE IS DATED 04/20/1995 AND THE HANDPIECE WAS QUITE BEYOND OF REPAIR. THE COMPANY ADVISED THE USER OF PROPER MAINTENANCE ACCORDINGLY THE USER'S GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 57E2 HANDPIECE DENTAL HANDPIECE EFB MICRO-MEGA 50102056 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other