BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTRAIT PSR3

    MDR report key: 1060888 · Received June 13, 2008

    Report

    Report Number
    3004948955-2008-00021
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 14, 2008
    Manufacturer
    RHYTEC INCORPORATED
    Product Code
    GEI
    PMA / PMN Number
    K071786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PT TREATED IN 2008 FOR COSMETIC WRINKLES USING THE PORTRAIT PSR3 COMPLAINED A WEEK AFTER THE PROCEDURE THAT SHE WAS DISSATISFIED WITH THE PROCEDURE, AND THAT THE PROVIDER HAD NOT TREATED THE AREA OF THE UPPER LIP. THE PT RECENTLY NOTIFIED RHYTEC THAT SHE HAD MOHS SURGERY FOUR MONTHS LATER TO REMOVE A BASAL CELL CARCINOMA. PICTURES PROVIDED BY THE PT SHOW THE AREA OF THE MOHS SURGERY ABUTTING THE UPPER RIGHT LIP. THE PORTRAIT PSR3 IS INDICATED TO TREAT WRINKLES AND ACTINIC KERATOSIS. THE PT WAS TREATED FOR WRINKLES; THE PROVIDER WAS NOT TREATING A PRECANCEROUS LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTRAIT PSR3 ELECTROSURGICAL CUTTING AND COAGULATION GEI RHYTEC INCORPORATED 745000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention