BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTENSE PULSE LIGHT DEVICE

    MDR report key: 3151797 · Received June 3, 2013

    Report

    Report Number
    MW5030448
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 3, 2013
    Manufacturer
    AESTHETIC AND CLINICAL DERMATOLOGY ASSOCIATES,
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT IN FOR AN INTENSE PULSE LIGHT TREATMENT AND CAME AWAY WITH FIRST DEGREE BURNS ON 95% OF MY FACE. SOMETHING WAS DONE INCORRECTLY OR THE MACHINE IS NOT CALIBRATED PROPERLY OR THE TECH MADE AN ERROR. I DO NOT KNOW THE BRAND OF THE DEVICE ONLY THE.... (B)(6) 2013. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242664 INTENSE PULSE LIGHT DEVICE GEX AESTHETIC AND CLINICAL DERMATOLOGY ASSOCIATES,

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other