BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHAROS EX-308 EXCIMER LASER

    MDR report key: 5141675 · Received October 8, 2015

    Report

    Report Number
    2032864-2015-00001
    Event Type
    Injury
    Date Received
    October 8, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 24, 2015
    Manufacturer
    RA MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT EXPERIENCED STRONG ERYTHEMA AND TRANSIENT BULLAE, A KNOWN SIDE EFFECT OF THE TREATMENT. THE PATIENT RESOLVED WITHOUT NEED FOR INTERVENTION, AND CONTINUED TREATMENT. THERE WAS NO EQUIPMENT MALFUNCTION. THE EQUIPMENT TESTED NORMALLY AND WITHIN CALIBRATION. OTHER PATIENTS TREATED WITHIN THE SAME TIMEFRAME EXPERIENCED NO ISSUES.

    Description of Event or Problem · 1

    A CHILD RECEIVING TREATMENT ON THE FACE FOR VITILIGO WAS TREATED. SHE WAS TREATED PER THE MANUFACTURER'S INSTRUCTIONS, AND PRESENTED THE FOLLOWING DAY WITH STRONG ERYTHEMA AND BULLAE. MEDICAL INTERVENTION WAS NOT REQUIRED, BUT TOPICAL ANTIBIOTICS WERE ADMINISTERED PROPHYLACTICALLY. THE BULLAE AND ERYTHEMA RESOLVED WITHOUT VISIBLE ALTERATION OF TISSUE (SCARRING), AND THE PATIENT HAS RESUMED TREATMENT. STRONG ERYTHEMA IS NOT AN A TYPICAL REACTION TO THIS TREATMENT, AND ALL REPORTED INCIDENTS TO DATE HAVE RESOLVED WITHOUT ANY VISIBLE ALTERATION OF TISSUE. NO MALFUNCTION OCCURRED, AND THE EQUIPMENT WAS TESTED AND FOUND TO BE OPERATING CORRECTLY. OTHER PATIENTS WERE TREATED IN THE SAME TIME FRAME WITH THE SAME EQUIPMENT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669562 PHAROS EX-308 EXCIMER LASER NONE GEX RA MEDICAL SYSTEMS, INC. EX-308

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other