BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHAROS EXCIMER LASER SYSTEM

    MDR report key: 11407680 · Received March 3, 2021

    Report

    Report Number
    2032864-2021-00002
    Event Type
    Injury
    Date Received
    March 3, 2021
    Date of Event
    January 31, 2021
    Report Date
    March 3, 2021
    Manufacturer
    RA MEDICAL SYSTEMS, INC
    Product Code
    GEX
    UDI-DI
    00842362100017
    PMA / PMN Number
    K062963
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE TECHNICIAN INSPECTED THE DEVICE AT THE USER FACILITY AND NO DEVICE DEFICIENCIES WERE OBSERVED. DEVICE WAS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TREATMENT FOR A DERMATOLOGICAL CONDITION ON THE LEGS AND ARMS, THE PATIENT EXPERIENCED UNEXPECTED ERYTHEMA WITH BLISTERING AND WEEPING. HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT IS HEALING WELL. USER FACILITY PROTOCOL TO TREAT ERYTHEMA IS TO APPLY A THIN LAYER OF HYTON WITH AQUAPHOR TWICE DAILY, IN ADDITION TO DECREASING THE DOSE BY 100-200 MJ/CM2 AND NOT TREATING EFFECTED AREAS UNTIL FULLY HEALED. HEALTHCARE PROFESSIONAL STATED THAT PATIENT HAS A HISTORY OF ERYTHEMA AFTER TREATMENT. THE DOSE DELIVERED AT TIME OF EVENT WAS 500 MJ/CM2. THE DOSE DELIVERED AT THE PREVIOUS TREATMENT WAS 400 MJ/CM2. REPORTEDLY, THE PATIENT HAD NOT APPLIED ANY TOPICALS OR PHOTOSENSITIZING AGENTS PRIOR TO TREATMENT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302036 PHAROS EXCIMER LASER SYSTEM EXCIMER PHOTOTHERAPY LASER GEX RA MEDICAL SYSTEMS, INC EX=308 00842362100017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention