BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICON LASER SYSTEM

    MDR report key: 3587249 · Received January 13, 2014

    Report

    Report Number
    1222993-2014-00004
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    March 1, 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 AND BLISTERS DEVELOPED IMMEDIATELY AFTER THE PROCEDURE. ONE BLISTER LEFT A SCAR ON THE PATIENT'S LEFT LOWER CHEEK. THE PHYSICIAN APPLIED ICE AND LOCOID LOTION POST PROCEDURE. THE PATIENT WAS COMPLIANT TO THE PHYSICIAN'S INSTRUCTIONS TO USE SUN BLOCK AND AVOID SUN EXPOSURE. THE PHYSICIAN FOLLOWED UP IN (B)(6)2013 AND THE SCAR WAS STILL VISIBLE. THE PHYSICIAN NOTED THAT THE FOOT PEDAL DID NOT RESPOND INTERMITTENTLY DURING THE CASE AND WAS DIFFICULT TO USE. THE PHYSICIAN RETURNED THE ICON LASER SYSTEM FOR EVALUATION. THERE IS A RELATED COMPLAINT 1222993-2014-00005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27028 ICON LASER SYSTEM ICON LASER SYSTEM GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention