BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615600 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00003
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    May 16, 2008
    Report Date
    May 20, 2008
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REPORTED EVENT BY SCITON CLINICAL STAFF CONCLUDED THAT THE PROBABLE ROOT CAUSE TO BE THE FAILURE TO MAINTAIN PROPER FLUID LEVEL IN THE CHILLER. THE TREATMENT PARAMETERS (VIZ., 80 JOULES, 20 MS, SPOT SIZE 5X5, 5 DEG C) WERE WITHIN REASONABLE RANGE FOR (B)(4) TYPE III SKIN. SCITON CLINICAL STAFF EVALUATED THE DEVICE AT CUSTOMER SITE AND FOUND NO MALFUNCTION OF THIS DEVICE. CUSTOMER REPORTED THAT THE TREATMENTS, ONE WITH EVEN DARKER (B)(4) SKIN TYPE, "WERE PERFECT".

    Description of Event or Problem · 1

    A CLINICIAN TREATING A PT FOR LASER HAIR REMOVAL ON UPPER LIP, CHIN, SIDEBURNS AND NECK REPORTED THAT THE PT WAS VERY RED AND THE UPPER CHEEKS WERE BLISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE 1064 NM LASER GEX SCITON, INC. PROFILE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA