BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTRAIT PSR3

    MDR report key: 1012567 · Received March 11, 2008

    Report

    Report Number
    3004948955-2008-00014
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    RHYTEC INCORPORATED
    Product Code
    GEI
    PMA / PMN Number
    K071786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT POST CARE INSTRUCTIONS STATE THAT PETROLATUM OR OTHER RECOVER BALM IS TO BE APPLIED IMMEDIATELY AFTER TREATMENT AND NOT WASHED OFF FOR THE FIRST 24 HOURS. AFTER THAT THE FACE IS TO CLEANSED AND PETROLATUM REAPPLIED TO KEEP THE SKIN MOIST UNTIL PEELING OCCURS. THIS USUALLY TAKES 3 TO 5 DAYS. THE PT WAS SEEN THE NEXT DAY WITH HER SKIN DRY.

    Description of Event or Problem · 1

    PATIENT TREATED WITH PORTRAIT PSR MAY HAVE DEVELOPED SLIGHT SCARRING AND PIGMENTATION CHANGES. THE PT WAS TREATED WITH HIGH ENERGY FULL FACE, BUT WENT TO WORK THE NEXT DAY AND DID NOT APPEAR TO BE FOLLOWING THE POST TREATMENT CARE INSTRUCTIONS.

    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 47 YR Required Intervention