BEUDAMED
    FDA Adverse Event Other Summary report: N

    RHYTEC PORTRAIT PSR3

    MDR report key: 681192 · Received February 27, 2006

    Report

    Report Number
    3004948955-2006-00001
    Event Type
    Other
    Date Received
    February 27, 2006
    Date of Event
    November 21, 2005
    Report Date
    February 27, 2006
    Manufacturer
    RHYTEC, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO RHYTEC INC, THAT A MISUSE EVENT MAY HAVE CAUSED A PATIENT TO EXPERIENCE TEXTURAL CHANGES TO HER JAW LINE AFTER PSR3 TREATMENT THAT MAY REQUIRE INTERVENTION TO PRECLUED TEMPORARY OR PERMANENT DAMAGE TO HER SKIN. THE TREATMENT RESULTS COULD HAVE BEEN RELATED TO AN EXCESSIVE AMOUNT OF PULSES AND AGGREGATE ENERGY AS RECOMMENDED IN THE DIRECTIONS FOR USE PROVIDED TO THE USER BY RHYTEC, INC. AS THE PATIENT HAS TO HEAL TWICE ONLY IN PARTIAL FACIAL AREAS. THE PATIENT CONTINUES TO RECEIVE FOLLOW-UP TREATMENT AT THE PHYSICIAN'S OFFICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention