BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTRAIT PSR3

    MDR report key: 1211027 · Received October 23, 2008

    Report

    Report Number
    3004948955-2008-00036
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    July 3, 2008
    Report Date
    September 23, 2008
    Manufacturer
    RHYTEC INCORPORATED
    Product Code
    GEI
    PMA / PMN Number
    K071786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING INSTRUCTS PATIENTS NOT TO REMOVE, PICK OR RUB AREAS OF THE SKIN AND TO CONTACT THEIR PHYSICIAN IMMEDIATELY IF THERE ARE SIGNS OF INFECTION AND THAT UNTREATED INFECTIONS MAY LEAD TO SCARS.

    Description of Event or Problem · 1

    PATIENT TREATED WITH PORTRAIT DEVELOPED A HYPERTROPHIC SCAR UNDER THE NOSTRIL. PATIENT ADMITTED TO PICKING AND SCRATCHING TREATED AREA AND SELF TREATING AREAS OF DELAYED HEALING. PATIENT WAS PRESCRIBED KEFLEX TO COVER STAPH INFECTION. THE SCAR WAS INJECTED WITH KENALOG AND TREATED WITH VBEAM PDL. NO VISIBLE IMPROVEMENTS HAVE BEEN NOTED TO DATE.

    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 60 YR Required Intervention