BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 357031 · Received October 16, 2001

    Report

    Report Number
    1720381-2001-00007
    Event Type
    Malfunction
    Date Received
    October 16, 2001
    Date of Event
    September 19, 2001
    Report Date
    September 25, 2001
    Manufacturer
    FISMA
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE DOCTOR RECEIVED A FLASHBACK OF LASER LIGHT AFTER GOING THROUGH THE STANDARD SAFETY PROTOCOL. THE EVENT HAPPENED TWICE. THERE WAS NO HARM TO THE PATIENT. THE DOCTOR WAS NOT INJURED AND FINISHED THE PROCEDURE WITHOUT USING THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46491 HGM SHUTTER LQJ FISMA K10-A-K03-1-87 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *