BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSCULPT

    MDR report key: 3245089 · Received January 11, 2013

    Report

    Report Number
    2954354-2013-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    CUTERA, INC.
    Product Code
    PBX
    PMA / PMN Number
    K122389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    COATING FAILURE OF TREATMENT SURFACE ON HANDPIECE. DEVICE OPERATOR USED THE DEVICE TO TEST ON ANOTHER PERSON - NOT A PATIENT. THE COATING FAILURE CAUSED A SMALL BURN THAT HAS HEALED WITHOUT MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19657 TRUSCULPT PBX CUTERA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR