BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR LASER SYSTEM

    MDR report key: 2143657 · Received January 12, 2006

    Report

    Report Number
    2950711-2006-00001
    Event Type
    Injury
    Date Received
    January 12, 2006
    Date of Event
    October 1, 2005
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON REPORTS FROM THE DR. (B)(6), THE TREATING PHYSICIAN, M0184 PERFORMED AS EXPECTED. REVIEW OF THE MANUFACTURING RECORDS FOR THE SYSTEM NOTED NO NON-CONFORMANCE RELATED TO THE EVENT. UPON EVAL EIGHT WEEKS POST-TREATMENT, THE INFRAORBITAL TREATMENT REGION WAS REPORTED TO BE IMPROVING BUT HAD NOT FULLY RESOLVED.

    Description of Event or Problem · 1

    ON (B)(6) 2005, PT WAS REPORTED TO HAVE DEVELOPED BILATERAL "EROSIONS" IN THE INFRAORBITAL REGIONS TREATED BY THE FRAXEL SR LASER SYSTEM. THE PT RECEIVED ONE TREATMENT WITH THE FRAXEL SR LASER SYSTEM AT A SETTING OF 2000 MTZ/CM2 AND 10MJ. FOLLOWING TREATMENT TWO, PT REPORTED PEELING BILATERALLY UNDER HER EYES AND SUBSEQUENTLY DEVELOPED SCAR TISSUE IN THE TREATED AREA. THE PHYSICIAN (DR. (B)(6)) REPORTED ON (B)(6) 2005 THAT HE ELECTED TO ADMINISTER A THERAPEUTIC REGIMEN IN ORDER TO MINIMIZE THE RISK FOR DEVELOPMENT OF SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR LASER SYSTEM SURGICAL LASER GEX RELIANT TECHNOLOGIES, INC. 00-00009

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention KENALOG, 40 MG| STEROIDS WERE INJECTED TO MANAGE THE POST-| KENALOG, 10 MG| OPERATIVE COMPLICATIONS WITHIN THE TREATED AREA.