BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMOPHARE

    MDR report key: 227090 · Received June 10, 1999

    Report

    Report Number
    MW1016497
    Event Type
    Malfunction
    Date Received
    June 10, 1999
    Date of Event
    April 4, 1999
    Report Date
    April 5, 1999
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    45 YR OLD FEMALE - RN ASSISTING DURING DELIVERY. PORTABLE PROCEDURE LIGHT FELL OFF STAND STRIKING EMPLOYEE IN LOWER BACK. 2 BOLTS HOLDING LIGHT COMPLETELY SHEARED OFF. EVALUATION OF EMPLOYEE IN EMERGENCY DEPT REVEALED ECCYMOTIC AREA AT BASE OF LUMBAR SPINE. NO SEQUELAE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE EXAM LAMP FQP BERCHTOLD CORP. C450 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other