BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLAZ PRO SYSTEM

    MDR report key: 2613471 · Received May 8, 2012

    Report

    Report Number
    2954746-2012-00004
    Event Type
    Injury
    Date Received
    May 8, 2012
    Date of Event
    February 15, 2012
    Report Date
    April 26, 2012
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISOLAZ SYSTEM IS INTENDED FOR: THE TREATMENT OF MILD TO MODERATE ACNE, INCLUDING PUSTULAR ACNE, COMEDONAL ACNE, AND MILD TO MODERATE INFLAMMATORY ACNE (ACNE VULGARIS). THE ISOLAZ SYSTEM IS CLEARED FOR USE ON ALL SKIN TYPES (FITZPATRICK SKIN TYPE I-VI). COMPLICATIONS AND ADVERSE EFFECTS STATED IN THE OPERATOR'S MANUAL INCLUDE: IN THE COURSE OF TREATMENT, THE FOLLOWING MINOR COMPLICATIONS MAY BE OBSERVED IN SOME PATIENTS: SUPERFICIAL EROSIONS OF THE TREATED AREA MAY BE VISIBLE AFTER TREATMENT. 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. MILD DISCOMFORT MAY OCCUR DURING TREATMENT. THE LEVEL OF DISCOMFORT VARIES FROM INDIVIDUAL TO INDIVIDUAL. THE USE OF TOPICAL ANESTHETIC CREAMS (SUCH AS LMX THAT DO NOT HINDER THE TRANSMISSION OF LIGHT IN THE 400-1200 NM WAVELENGTH) MAY BE HELPFUL. LOCAL ANESTHESIA IS, HOWEVER, NOT GENERALLY REQUIRED. IN RARE CASES, BLISTERING, PURPURA OR BRUISING, CONFINED TO THE EXPOSURE AREA, MAY BE EVIDENT FOR 1-3 DAYS FOLLOWING TREATMENT.

    Description of Event or Problem · 1

    SOLTA MEDICAL, INC. RECEIVED A MEDWATCH REPORT, (B)(4) FROM (B)(6) ON (B)(6) 2012. IT DESCRIBES AN EVENT REPORTED ON (B)(6) 2012, BY A PATIENT WHO UNDERWENT AN ISOLAZ PROCEDURE TO TREAT MILD ACNE ON HER FACE. THE PATIENT WAS UNABLE TO TOLERATE THE PAIN WHILE THE TREATMENT WAS BEING PERFORMED; SHE REPORTED FEELING A BURNING SENSATION, SO THE TREATMENT WAS STOPPED AND SHE WAS SENT HOME. WITHIN ONE HOUR AFTER TREATMENT, THE PATIENT WENT TO THE HOSPITAL DUE TO MARKS THAT APPEARED ON HER FACE. THE HOSPITAL DID NOT PROVIDE TREATMENT, BUT REFERRED HER TO A DERMATOLOGIST. SHE RETURNED TO THE PLACE WHERE SHE HAD RECEIVED HER TREATMENT AND SHE WAS DIAGNOSED WITH BRUISING AND HYPERPIGMENTATION WHICH THE DERMATOLOGIST SAID WOULD TAKE SEVERAL MONTHS TO CLEAR. SHE CONSULTED ANOTHER DERMATOLOGIST WHO DIAGNOSED HER WITH BURNS, HYPERPIGMENTATION, AND HYPOPIGMENTATION. ANTIBIOTICS AND CORTICOSTEROIDS WERE PRESCRIBED TO PREVENT SCARRING. THE MARKS ON THE PATIENT'S FACE HAVE PEELED OFF AND NOW THERE IS HYPOPIGMENTATION. THE PATIENT IS USING VITAMIN E OIL AND BELIEVES THAT HYPO-PIGMENTATION WILL HEAL PER THE DERMATOLOGIST ADVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLAZ PRO SYSTEM ELECTROSURGICAL UNIT AND ACCESSORIES GEI SOLTA MEDICAL, INC. Z40009

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability ANTIBIOTICS: (UNKNOWN BRAND)| CORTICOSTEROIDS: (UNKNOWN BRAND)