BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON LASER SYSTEM

    MDR report key: 3587235 · Received January 13, 2014

    Report

    Report Number
    1222993-2014-00005
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    April 12, 2013
    Report Date
    January 13, 2014
    Product Code
    GEX
    PMA / PMN Number
    K110907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICON LASER SYSTEM WAS TESTED AND FOUND TO HAVE NO PROBLEM. IT DID NOT SHUT DOWN AND IT PULSED FINE WITH A NEW FOOT PEDAL. THE FOOT PEDAL WAS NOT RETURNED WITH THE LASER AND THUS UNABLE TO CONFIRM IF THERE WERE ANY ISSUES. MAXIR HAND PIECE: NO PROBLEMS FOUND.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING THE PATIENT'S CHEEKS AND NECK AND A SCAR ON THE RIGHT SIDE OF THE NECK WAS NOTICED SECONDARY TO A BLISTER DEVELOPING ON THE NECK. THE PHYSICIAN RETURNED THE ICON LASER SYSTEM FOR EVALUATION. THERE IS A RELATED COMPLAINT 1222993-2014-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24263 ICON LASER SYSTEM ICON LASER SYSTEM GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention