BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BURTON OVERHEAD MOUNTED EXAM LIGHT

    MDR report key: 278598 · Received May 19, 2000

    Report

    Report Number
    MW1018936
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Date of Event
    January 1, 1998
    Report Date
    May 19, 2000
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES THAT THE RETAINING BOLTS STRIP VERY EASILY, CAUSING THE FIXTURE TO FALL. THE RPTR STATES THAT THE MFR IS WELL AWARE OF THE DESIGN FLAW AND HAD BEEN OFFERING A REPAIR KIT FREE OF CHARGE FOR THE PAST THREE YEARS. HOWEVER, THE MFR IS NOW ONLY OFFERING A 50% DISCOUNT ON THE KIT. THE RPTR FEELS THAT DEVICES SHOULD HAVE BEEN RECALLED OR AT LEAST, MANDATORILY RETRO-FIT BY THE MFR FREE OF CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BURTON OVERHEAD MOUNTED EXAM LIGHT OVERHEAD MOUNTED EXAM LIGHT FTD BURTON MEDICAL PRODUCTS CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA