BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHAROS EXCIMER LASER SYSTEM

    MDR report key: 8916413 · Received August 21, 2019

    Report

    Report Number
    2032864-2019-00005
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Report Date
    August 21, 2019
    Manufacturer
    RA MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    UDI-DI
    00842362100017
    PMA / PMN Number
    062963
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE TECHNICIAN INSPECTED THE DEVICE AND FOUND THAT BELOW A SETTING OF 100 MJ, THE DEVICE CONTINUED TO DOSE AS LONG AS THE FINGER FIRE BUTTON WAS PRESSED. THIS WAS CONFIRMED BY AN ENGINEERING EVALUATION AT THE MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE MALFUNCTIONED ON (B)(6) 2019. THIS WAS FOLLOWED BY A REPORT ON (B)(6) 2019 OF A PATIENT EXPERIENCING ERYTHEMA AFTER TREATMENT WITH THE EX-308.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712469 PHAROS EXCIMER LASER SYSTEM EXCIMER PHOTOTHERAPY LASER GEX RA MEDICAL SYSTEMS, INC. EX-308 00842362100017

    Patients

    Seq Age Sex Outcome Treatment
    1