BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRACTAL LASER

    MDR report key: 2213275 · Received August 10, 2011

    Report

    Report Number
    MW5021726
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    June 15, 2011
    Report Date
    August 10, 2011
    Product Code
    ONG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FRACTAL LASER USED FOR SCARRING REMOVAL. CAUSED MORE PITTING AND SCARRING PERMANENTLY. RUINED LIFE AND MARRIAGE AND HOME. (B)(6) IS PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRACTAL LASER ONG

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention