BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5091470

    MDR report key: 5091470 · Received September 17, 2015

    Report

    Report Number
    5091470
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 17, 2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHILD RECEIVING LASER TREATMENT TO FACE FOR VITILIGO. MACHINE HAD RECENTLY BEEN CALIBRATED AND COMPANY ADVISED 40% REDUCTION IN STRENGTH. PRACTITIONER FOLLOWED COMPANY RECOMMENDATIONS. CHILD SUSTAINED REDNESS AND BLISTERING OF FACE.

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention