BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTRAIT PSR3

    MDR report key: 1211085 · Received October 24, 2008

    Report

    Report Number
    3004948955-2008-00037
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 24, 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

    THE PORTRAIT DEVICE DOES NOT TOUCH THE PT'S SKIN. THE PHYSICIAN'S GUIDE AND PT GUIDE RECOMMEND PETROLATUM/PETROLEUM JELLY BE APPLIED TO THE TREATED AREA DURING HEALING.

    Description of Event or Problem · 1

    PT DEVELOPED AN INFECTION ON THE CHEEK AND INFRAORBITAL AREAS 1.5 DAYS AFTER USING A COPPER/ZINC-OXIDE TOPICAL AGENT RATHER THAN THE RECOMMENDED PETROLATUM-BASED OINTMENT. KEFLEX WAS PRESCRIBED; THE INFECTED AREA IS HEALING MORE SLOWLY RELATIVE TO THE REST OF THE TREATED AREAS.

    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 59 YR Required Intervention