BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCULPT

    MDR report key: 2872552 · Received June 13, 2012

    Report

    Report Number
    2954354-2012-00015
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 13, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    NUV
    PMA / PMN Number
    K092195
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS EVALUATED; THE ROOT CAUSE WAS LOSS OF DIELECTRIC CONTACT DUE TO THE FILM LIFTING.

    Description of Event or Problem · 1

    BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUSCULPT CUTERA CMMCD NUV CUTERA, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention