BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSCCULPT

    MDR report key: 3840654 · Received August 20, 2013

    Report

    Report Number
    2954354-2013-00018
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    August 12, 2013
    Report Date
    August 12, 2013
    Manufacturer
    CUTERA, INC.
    Product Code
    PBX
    PMA / PMN Number
    K122389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE TO BE COMPLETED. DEVICE IS PENDING RETURN TO CUTERA.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A SMALL WELT AFTER THE PROCEDURE. THE WELT PROGRESSED TO BURN. THE PATIENT REQUIRED PRESCRIPTION TOPICAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404305 TRUSCCULPT MASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT PBX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention