BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR 1500 LASER SYSTEM

    MDR report key: 2171388 · Received February 22, 2007

    Report

    Report Number
    2950711-2007-00002
    Event Type
    Injury
    Date Received
    February 22, 2007
    Date of Event
    February 15, 2006
    Report Date
    February 22, 2007
    Manufacturer
    RELIANT TECHNOLOGIES
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DR (B)(6) HAD REPORTED THAT NO CONCOMITANT MEDICAL PRODUCTS HAD BEEN USED. BASED ON REPORTS FROM DR (B)(6), THE TREATING PHYSICIAN, SYSTEM (B)(4) WAS RETURNED TO RELIANT AND EVALUATED. THE SYSTEM WAS FOUND TO BE FULLY WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2006, DR (B)(6) TREATED THE BACK OF THE HAND OF ONE OF HIS STAFF MEMBERS WITH 38MJCM TO THE POWER OF 2, DENSITY 8MTZ/CM TO THE POWER OF 2, 6 PASSES DURING A DEMONSTRATION, SO SHE COULD EVALUATE THE PAIN LEVELS, DOWN TIME AND RESPOND WITH AN AGGRESSIVE TREATMENT. ON (B)(6) 2006, DR (B)(6) NOTIFIED THE RELIANT SALES REPRESENTATIVE AND REPORTED THE PATIENT WAS OVER-TREATED AND THAT THE TREATMENT AREA HAD A BURN. ON (B)(6) 2007, THE PHYSICIAN REPORTED THAT THE STAFF MEMBER'S TREATMENT HAD RESULTED IN A PERMANENT HYPERTROPHIC SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR 1500 LASER SYSTEM SURGICAL LASER GEX RELIANT TECHNOLOGIES 01-02628 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability