BEUDAMED
    FDA Adverse Event Summary report: N

    ALTUS COOLGLIDE

    MDR report key: 458737 · Received May 8, 2003

    Report

    Report Number
    MW1028358
    Date Received
    May 8, 2003
    Date of Event
    February 28, 2003
    Report Date
    May 8, 2003
    Manufacturer
    ALTUS MEDICAL, INC.
    Product Code
    GEX
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES WHILE THEY WERE GETTING A PHOTO FACIAL, THEIR EYES WERE BURNED, EVEN THOUGH METAL EYE PROTECTORS WERE USED. MEDIAL ASPECT OF EYELID WAS BLACKENED. BACITRACIN WAS APPLIED TO BURN AND ALSO GENTIMYCIN EYE DROPS WERE APPLIED TID. STATES 300 JOULES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTUS COOLGLIDE YAG LASER GEX ALTUS MEDICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR