BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HGM

    MDR report key: 180826 · Received July 29, 1998

    Report

    Report Number
    1720381-1998-00007
    Event Type
    Malfunction
    Date Received
    July 29, 1998
    Date of Event
    June 26, 1998
    Report Date
    June 29, 1998
    Manufacturer
    FISMA, INC.
    Product Code
    LQJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REC'D EXPOSURE WHEN THE RIGHT FILTER TO HIS PLANAR F FELL OUT OF ITS HOLDER. PHYSICIAN STATED THAT HE DID NOT NOTICE THE FILTER WAS MISSING UNTIL AFTER COMPLETING THE PROCEDURE (LASER TREBECULAPLASTIE AT THE POWER SETTING OF 600 MILLIWATTS). HE ALSO STATED THAT HE DID NOT RECEIVE ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM LASER SLIT LAMP ATTACHMENT LQJ FISMA, INC. A01-A-K03-0-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other