BEUDAMED
    FDA Adverse Event Summary report: N

    HGM DENTAL 200

    MDR report key: 74623 · Received March 7, 1997

    Report

    Report Number
    MW1010906
    Date Received
    March 7, 1997
    Manufacturer
    HGM MEDICAL LASER SYSTEMS, INC.
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    WHEN THE LASER IS USED, THE EXPOSED SKIN OF THE DR, ASSISTANT, AND PT TURNS RED, LIKE A SUNBURN. THIS USUALLY LASTS FOR A PERIOD OF 5-10 MINS THEN GOES AWAY. USER HAS TALKED WITH OTHER PEOPLE WHO USE THE SAME LASER AND THEY DO NOT EXPERIENCE THIS REDNESS. USER WONDERS IF IT IS NOT SOME TYPE OF RADIATION OR ARGON LEAK. USER IS CONCERNED ABOUT THEIR LASER. THE DR'S EYE PRESCRIPTION HAS BEEN CHANGED THREE TIMES SINCE PURCHASING THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM DENTAL 200 LASER GEX HGM MEDICAL LASER SYSTEMS, INC. E02-B-A03-2-01 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *