BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLAZ PRO SYSTEM

    MDR report key: 2593432 · Received May 25, 2012

    Report

    Report Number
    2954746-2012-00005
    Event Type
    Injury
    Date Received
    May 25, 2012
    Date of Event
    May 23, 2008
    Report Date
    April 27, 2012
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEI
    PMA / PMN Number
    K083730
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: IN THE COURSE OF TREATMENT, THE FOLLOWING MINOR COMPLICATIONS MAY BE OBSERVED IN SOME PTS: FRAGILITY OF SKIN SURROUNDING THE TREATMENT AREA. IF THIS HAPPENS, DO NOT RUB THE SKIN. SUPERFICIAL EROSIONS OF THE TREATED AREA MAY BE VISIBLE AFTER TREATMENT. 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

    ON (B)(6) 2012, SOLTA MEDICAL RECEIVED A COMPLAINT FROM A PT STATING SHE RECEIVED "LESIONS" FOLLOWING AN ISOLAZ TREATMENT PERFORMED ON (B)(6) 2008. THE PT REPORTED THAT SHE HAD SENT ORIGINAL COMPLAINT IN 2008 TO AESTHERA, PRIOR TO SOLTA ACQUIRING AESTHERA IN 2009, HOWEVER NO RECORD OF COMPLAINT WAS FOUND. IN SPEAKING WITH THE TREATING PHYSICIAN, DR. (B)(6) REGARDING PT'S COMPLAINT, HE STATED THAT HE PERFORMED SEVERAL 1540 LASER TREATMENTS TO SPEED HEALING HOWEVER THE PT'S CONDITION MAY HAVE RESOLVED OVER TIME WITHOUT INTERVENTION. HE SAW PT A MONTH AGO AND REPORTS SHE HAS VERY MINIMAL SCARRING AND OVERALL LOOKS GOOD. HE DOES NOT KNOW IF A DEVICE MALFUNCTION OCCURRED DURING THE TREATMENT OR WAS CAUSAL TO THE INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability