BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON LASER SYSTEM

    MDR report key: 3720581 · Received March 27, 2014

    Report

    Report Number
    1222993-2014-00009
    Event Type
    Injury
    Date Received
    March 27, 2014
    Report Date
    March 26, 2014
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS DEVICE IS ONGOING. ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    PATIENTS TREATED WITH 1540 HANDPIECE DEVELOPED A SCAR. THERE IS A RELATED MEDWATCH REPORT 1222993-2014-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179448 ICON LASER SYSTEM ICON LASER SYSTEM GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other