BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPOT PHOTOTHERAPY WALL MOUNT LIGHT

    MDR report key: 449820 · Received March 17, 2003

    Report

    Report Number
    2018492-2003-00010
    Event Type
    Other
    Date Received
    March 17, 2003
    Date of Event
    May 1, 2002
    Report Date
    March 17, 2003
    Manufacturer
    BURTON MEDICAL PRODUCTS CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    END USER REPORTED THAT WHILE AN EXAMINATION WAS BEING PERFORMED ON A PATIENT, THE FLOOR MOUNT LIGHT WAS BEING REPOSITIONED. DURING RESPOSITIONING, THE LAMP SWUNG AROUND AND STRUCK PATIENT IN THE EYE. THE MECHANICAL STOP WAS SAID TO HAVE FAILED. USER STATED THAT EVENT WAS RE-ENACTED IN 2002 AND CONCLUDED THAT FIRM BUY NOT EXCESSIVE FORCE CAUSED OVERCOMING OF THE MECHANICAL STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPOT PHOTOTHERAPY WALL MOUNT LIGHT ALL MOUNT FSY BURTON MEDICAL PRODUCTS CORP. 0224100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other