BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 306083 · Received November 17, 2000

    Report

    Report Number
    1720381-2000-00004
    Event Type
    Malfunction
    Date Received
    November 17, 2000
    Date of Event
    September 28, 2000
    Report Date
    November 14, 2000
    Manufacturer
    FISMA
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SHUTTER DID NOT COVER LENS WHEN LASER FIRED. IT WAS REPORTED THAT THE DOCTOR AND THE ASSISTANT WERE NOT INJURED. ALSO THERE WAS NO PT INVOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other