BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615597 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00002
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    May 9, 2008
    Report Date
    May 12, 2008
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IT WAS REPORTED BY THE DOCTOR'S OFFICE THAT "SOMEONE MADE A HOLE IN THE TUBING WITH THE LASER AND IT HAD BEEN LEAKING." THE TREATMENT PARAMETERS (VIZ., 77 JOULES, 20 MS AT 5 DEG C) WERE WITHIN REASONABLE RANGE FOR (B)(4) TYPE III SKIN. NO MALFUNCTION OF THE DEVICE WAS REPORTED WITH THIS EVENT. SCITON'S CLINICAL STAFF CONCLUDED THAT THE CAUSE OF INJURY WAS NOT RELATED TO THE LASER PERFORMANCE/OUTPUT AND SO A SERVICE CALL WAS NOT INITIATED.

    Description of Event or Problem · 1

    A CLINICIAN TREATING A (B)(4) TYPE III PT FOR HAIR REMOVAL REPORTED THAT THE PT RECEIVED SMALL BLISTERS BELOW THE LIP LINE AT THE CREASE WHERE THE CHIN BEGINS. APPROX 2 WEEKS LATER, THE DOCTOR'S OFFICE REPORTED THAT THE PT HAS HEALED WITHOUT ANY PROBLEM.

    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