BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGM INC

    MDR report key: 405705 · Received July 2, 2002

    Report

    Report Number
    405705
    Event Type
    Injury
    Date Received
    July 2, 2002
    Date of Event
    May 15, 2002
    Report Date
    June 5, 2002
    Manufacturer
    HGM INC (LUMENIS)
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT LASER TREATMENT SESSION #1. CONTACT LENS FELL OUT ON MORE THAN ONE OCCASION. SOME LASER SPOTS WERE DIVERTED TO CENTRAL VISUAL AREA CAUSING DIMINISHED VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM INC LASER HQF HGM INC (LUMENIS) E 50-3-K05-2-02 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR