BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPILIGHT

    MDR report key: 245542 · Received October 21, 1999

    Report

    Report Number
    MW1017363
    Event Type
    Injury
    Date Received
    October 21, 1999
    Date of Event
    October 6, 1999
    Report Date
    October 21, 1999
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER'S DAUGHTER HAD TREATMENT (FIRST) WITH DEVICE ON EYEBROWS AND ABOVE UPPER LIP. A CONDUCTING GEL WAS PLACED OVER EYEBROWS AND COTTON GAUZE LAYERED OVER EYELIDS. THE DEVICE "CAMERA" WAS LOWERED AND SHORT PULSES OF LIGHT GIVEN FOR HAIR REMOVAL. WHEN DAUGHTER WENT OUTSIDE, AFTER TREATMENT, SHE FELT AS IF SHE NEEDED TO SHIELD HER EYES. THE PAIN WORSENED THAT NIGHT AND HER EYES WERE RED. THE NEXT DAY THE PAIN INCREASED. THE FOLLOWING DAY THE PAIN HAD WORSENED AND DERMATOLOGIST WAS NOTIFIED, WHO FELT IT WAS A REACTION TO THE GEL, BUT DAUGHTER STATES THE AL0E VERA GEL NOR THE CONDUCTING GEL GOT INTO HER EYES. HER SKIN DID NOT APPEAR ANY MORE UNUSUAL THAN WITH A REGULAR EPILATOR TREATMENT. SHE WAS REFERRED TO THE OPHTHAMOLOGIST, WHO FELT IT LOOKED LIKE A "WELDER'S" BURN. HE WAS CONVINCED IT WAS A BURN FROM AN ULTRAVIOLET LIGHT. OPHTHAMOLOGIST GAVE EYE DROPS AND INSTRUCTED PT TO STOP USING HER CONTACT LENSES. SHE WAS NOT ABLE TO RESUME USE OF THEM UNTIL 10 DAYS AFTER INITIAL EPILIGHT TREATMENT. HER CONTACTS WERE IN AT THE TIME OF THE TREATMENT AND OPHTHAMOLOGIST FELT THEY MIGHT HAVE HELPED PROTECT THAT AREA SINCE IT WAS THE SCLERA THAT WAS BURNED. DERMATOLOGIST'S OFFICE CONTACTED MFR WHO CLAIMED THAT IT WAS A REACTION TO THE GEL. REPORTER ALSO STATES THAT THE LEFT EYE WAS GIVEN EXTRA PULSES OF LIGHT AND THAT EYE WAS MORE IMMEDIATELY EFFECTED BUT SEEMED TO HEAL MORE QUICKLY. DAUGHTER HAD NO PROBLEMS WITH THE LIP AREA. REPORTER WORE GOGGLES WHILE IN ATTENDANCE AT THE TREATMENT AND FELT THE PULSES OF LIGHT DID SEEM INTENSE EVEN WITH THE GOGGLES ON. DERMATOLOGIST SAID THE DEVICE WAS NOT A LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILIGHT LIGHT EPILATOR (NOT LASER) GEX ESC MEDICAL SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention CONDUCTING GEL, ALOE VERA GEL.