BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHOTODERM VL

    MDR report key: 264469 · Received February 22, 2000

    Report

    Report Number
    MW1018213
    Event Type
    Other
    Date Received
    February 22, 2000
    Date of Event
    February 11, 2000
    Report Date
    February 21, 2000
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RPTR HAD A PHOTODERM TREATMENT FOR FACIAL TELANGECTIASES. DURING THE TREATMENT, RPTR EXPERIENCED EXCRUCIATING EYE PAIN, COMPLAINING OF PAIN FROM THE FLASHES OF LIGHT THROUGHOUT THE TREATMENT. AT THE END OF TREATMENT, WHEN RPTR REMOVED THE "PROTECTIVE" GOGGLES, THEY FOUND THEIR EYES TO BE SEVERELY SWOLLEN, ALL BLOOD VESSELS FULLY DILATED, SCLERA SWOLLEN, WITH COPIOUS TEARING; HORRIBLY PAINFUL. DERMATOLOGIST STATED THEY FELT "PROTECTIVE" GOGGLES WERE SUFFICIENT- RPTR DOESN'T THINK SO. EYES FELT VERY DRY AND SORE FOR FIVE DAYS, UNABLE TO PRODUCE TEARING. RPTR NOTED SMALL BROWN SPOTS ON SCLERA AFTER ONE WEEK RPTR DOESN'T USUALLY LOOK AT THEIR SCLERA UP CLOSE- WHICH ARE NOW FADING. EYES STILL FEEL SORE. AS A REGISTERED NURSE RPTR JUST WANTS THIS NOT TO HAPPEN TO ANYONE ELSE- "IT WAS PURELY AWFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOTODERM VL HIGH INTENSITY LIGHT THERAPY FOR VASCULAR LESIONS GEX ESC MEDICAL SYSTEMS, INC. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other