BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLUE SHINE LASER

    MDR report key: 2574877 · Received May 8, 2012

    Report

    Report Number
    MW5025354
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 8, 2012
    Manufacturer
    HYPERION MEDICAL
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS HAVING MY TOE NAIL FUNGUS TREATED WITH A LASER IN (B)(6) AND A LASER PROVIDED BY (B)(6) MALFUNCTIONED AND THERE WAS NO REMOTE DISCONNECT SWITCH BY THE DOOR FOR THE DEVICE. AS PER THEIR MANUAL AND I BELIEVE YOUR CODE THERE IS SUPPOSED TO BE REMOTE DISCONNECT FOR ALL LASERS BY THE DOOR THAT ENTERS THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLUE SHINE LASER 980 DIODE GEX HYPERION MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other