BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4120832 · Received September 12, 2014

    Report

    Report Number
    4120832
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 12, 2014
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    THE SURGICAL LIGHTS DRIFT. WHEN THE LIGHT WAS BEING DIRECTED INTO THE WOUND THE LIGHT COVER FELL ONTO THE STERILE MAYO STAND. THE LIGHT HANDLE COVER WAS REMOVED AND CONTAMINATED AREA COVERED WITH A STERILE TOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565216 * LIGHT, SURGICAL FSY BERCHTOLD CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR