BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTRAIT PSR3

    MDR report key: 1040165 · Received May 9, 2008

    Report

    Report Number
    3004948955-2008-00019
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    November 1, 2007
    Report Date
    April 8, 2008
    Manufacturer
    RHYTEC, INC.
    Product Code
    GEI
    PMA / PMN Number
    K071786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABELING WARNS THAT A TEST PATCH SHOULD BE CONDUCTED ON THE PTS WITH TYPE IV SKIN BEFORE THE FULL TREATMENT IS DONE. THERE IS NO INDICATION THAT A TEST PATCH WAS DONE.

    Description of Event or Problem · 1

    PT WITH TYPE IV SKIN DEVELOPED PROLONGED HYPERPIGMENTATION THAT HAS PERSISTED FOR SEVERAL MONTHS, AND IS BEING TREATED WITH TOPICAL MEDICATIONS AND EXFOLIATING CREAMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention