BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR LASER SYSTEM

    MDR report key: 2923261 · Received October 26, 2006

    Report

    Report Number
    2950711-2006-00004
    Event Type
    Injury
    Date Received
    October 26, 2006
    Date of Event
    August 18, 2006
    Report Date
    October 24, 2006
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON REPORTS FROM DR. (B)(6), THE TREATING PHYSICIAN, (B)(4) PERFORMED AS EXPECTED. FOLLOWING REVIEW OF THE MANUFACTURING RECORDS FOR THE SYSTEM IT WAS CONFIRMED THAT THERE WAS NO DEVICE NON-CONFORMANCE RELATED TO THE EVENT. PIGMENTARY ALTERATION IS LISTED AS A POTENTIAL COMPLICATION AND MAY BE ASSOCIATED WITH LASER TREATMENTS. IN ADDITION, USE OF RETINOIDS IS LISTED IN THE OPERATOR'S MANUAL AS A CONTRAINDICATION FOR FRAXEL LASER TREATMENT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    ON (B)(6) 2006, PATIENT WAS REPORTED TO HAVE SUSTAINED A PIGMENTARY ALTERATION IN THE AREA TREATED BY THE FRAXEL SR LASER SYSTEM. THE PATIENT RECEIVED ONE TREATMENT WITH THE FRAXEL SR LASER SYSTEM AT A SETTING OF 15 MJ AND 1000, MTZ/CM2 ON (B)(6) 2006. FOLLOWING THE TREATMENT, SOME IMMEDIATE BLISTERINGS WAS OBSERVED. APPROXIMATELY 72 HOURS POST-TREATMENT, THE PATIENT RECEIVED A STEROID INJECTION FROM AN INDEPENDENT PHYSICIAN TO MANAGE SYMPTOMS FROM THE TREATMENT. THE TREATING PHYSICIAN FIRST DESCRIBED A POSSIBLE POST-TREATMENT PIGMENTARY ALTERATION TO THE MANUFACTURER ON (B)(6) 2006. AT THAT TIME, THE TREATING PHYSICIAN WAS REPORTED THAT THE PATIENT HAD APPLIED A RETINOID TOPICAL PRODUCT, WHICH IS A LISTED CONTRAINDICATION TO FRAXEL LASER TREATMENT, PRIOR TO HER PROCEDURE. ALTHOUGH 30% RESOLUTION IN THE PATIENT'S PIGMENTARY ALTERATION WAS OBSERVED 6 WEEKS POST-TREATMENT, THE TREATING PHYSICIAN INDICATED THAT MEDICAL INTERVENTION WAS NECESSARY IN ORDER TO AVOID A LASTING EFFECT FROM THE ADVERSE SEQUELAE. ORAL ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR LASER SYSTEM SURGICAL LASER SYSTEM GEX RELIANT TECHNOLOGIES, INC. 00-01680-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention RESULT OF THE THERAPIES ((B)(4) 2006)| A STEROID INJECTION WAS ADMINISTERED THREE DAYS| ORAL ANTIBIOTICS, 10 DAY COURSE| KENALOG| POST-TREATMENT, THE TREATING PHYSICIAN REPORTED| FOLLOWING THE FRAXEL LASER TREATMENT TO MANAGE| THAT THE PATIENT'S CONDITION WAS IMPROVING AS A| SYMPTOMS WITHIN THE TREATED AREA| AFTER EVALUATING THE PATIENT SIX WEEKS