BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLAZ SYSTEM

    MDR report key: 2872712 · Received December 13, 2012

    Report

    Report Number
    2954746-2012-00016
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEX
    PMA / PMN Number
    K083730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. MANUFACTURER FOLLOW-UP DETERMINED THE AESTHETICIAN WAS UNAWARE THAT THERE IS A 580 NM MEDIUM TIP; RECOMMENDED FOR USE ON A HIGHER SKIN TYPE. THE USER MANUAL CONTAINS A TREATMENT PARAMETER TABLE TO HELP GUIDE THE USER TO ESTABLISH THE CORRECT TREATMENT PARAMETERS FOR SPECIFIC SKIN TYPES AND CONDITIONS. THE USER MANUAL STATES: IN THE COURSE OF TREATMENT, THE FOLLOWING MINOR COMPLICATIONS MAY BE OBSERVED IN SOME PATIENTS: CHANGE IN PIGMENTATION (HYPERPIGMENTATION OR HYPOPIGMENTATION) MAY SOMETIMES OCCUR AFTER TREATMENT. IN THE MAJORITY OF CASES, THIS PIGMENTARY CHANGE WILL RESOLVE OVER TIME. COMPLICATIONS ARISING FROM PIGMENTARY CHANGES HAVE BEEN RATED AS BOTH TRANSIENT AND MINOR AND APPEAR TO TYPICALLY RESOLVE SPONTANEOUSLY OVER SEVERAL MONTHS. ONLY IN VERY RARE CASES WILL THE CHANGE IN PIGMENT BE PERMANENT.

    Description of Event or Problem · 1

    A PATIENT WHO RECEIVED TREATMENT DUE TO ACNE REPORTED HYPOPIGMENTATION A DAY AFTER THE PROCEDURE. THE PROCEDURE WAS PERFORMED WITH THE 400 NM SMALL TIP AT THE LOWEST ENERGY SETTING. THE PATIENT WAS PRESCRIBED OBAGI AND RETIN-A; AFTER 2 WEEKS, NO IMPROVEMENT WAS OBSERVED. PER THE AESTHETICIAN, THE PATIENT IS CONTINUING THE OBAGI REGIMEN AND IS SCHEDULED FOR A FOLLOW UP IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLAZ SYSTEM LASER SURGICAL INSTRUMENT GEX SOLTA MEDICAL, INC. 50-07040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other