BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSHEER (ALL MODELS)

    MDR report key: 681430 · Received March 2, 2006

    Report

    Report Number
    2914019-2005-00058
    Event Type
    Injury
    Date Received
    March 2, 2006
    Date of Event
    October 26, 2005
    Report Date
    March 2, 2006
    Manufacturer
    *
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SIX PATIENTS WERE BURNED AT THE USUAL SETTINGS PER CONTACT. TEST SPOTS WERE PERFORMED. PATIENTS CALLED BACK AFTER THE TREATMENTS TO NOTIFY CUSTOMER OF DARK PIGMENTATIONS. CUSTOMER DID NOT RETURN COMPLETED DATA SHEETS BUT DID PROVIDE PARTIAL TREATMENT PARAMETERS BY TELEPHONE. BURNS RANGED FROM SUPERFICIAL TO SECOND DEGRESS AND OCCURRED DURING THE PERIOD 10/2005-11/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER (ALL MODELS) SOLID STATE AESTHETIC LASER GEX * LIGHTSHEER XC *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention