BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M22

    MDR report key: 4119561 · Received September 25, 2014

    Report

    Report Number
    3004135191-2014-00058
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 24, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K083733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS IS CURRENTLY INVESTIGATING THE REPORTED EVENT. WHEN RELEVANT INFORMATION IS PROVIDED TO LUMENIS BY THE PHYSICIAN REGARDING THIS REPORT, LUMENIS WILL FILE A FOLLOW-UP MEDWATCH REPORT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE PATIENT SUSTAINED BURNS TO THE LOWER LEGS FOLLOWING TREATMENT WITH A LUMENIS M22 LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598722 M22 INTENSE PULSE LIGHT DELIVERY DEVICE GEX LUMENIS, LTD. M22

    Patients

    Seq Age Sex Outcome Treatment
    1 Other