BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RE: STORE DUAL

    MDR report key: 7477890 · Received May 1, 2018

    Report

    Report Number
    3011423170-2018-00034
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    November 1, 2016
    Report Date
    April 3, 2018
    Manufacturer
    SOLTA MEDICAL INC
    Product Code
    GEX
    PMA / PMN Number
    K130193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED BY THE TREATING PHYSICIAN. THE INVESTIGATION WAS CONDUCTED BASED ON THE INFORMATION WE RECEIVED FROM THE CUSTOMER. ACCORDING TO FRAXEL RE:PAIR USER MANUAL, POST INFLAMMATORY HYPERPIGMENTATION (PIH) OR HYPO PIGMENTATION ARE KNOWN COMPLICATIONS OF MANY LASER TREATMENTS. IN PATIENTS WHO ARE PRONE TO PIH, BLEACHING AGENTS ARE USED BEFORE AND RESUMED ONE WEEK AFTER THE TREATMENTS TO AVOID SKIN IRRITATION. PIH IS GENERALLY TRANSIENT, LASTING FROM WEEKS, UP TO 3 MONTHS. THE CONDITION WILL BE HASTENED/WORSENED IF THE PATIENT IS NOT COMPLIANT WITH SUN PROTECTION/AVOIDANCE. IN THIS PARTICULAR CASE, NO PICTURES WERE PROVIDED AND NO REPORT OF SYSTEM ISSUES DURING TREATMENT BY THE PATIENT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A (B)(6) PATIENT WHO HAD A FRAXEL TREATMENT FOR ACNE DONE IN LONDON, UNITED KINGDOM. BOTH SIDES OF THE PATIENT'S FACE WERE TREATED FROM TEMPLE TO CHEEKS. THE PATIENT INDICATED THAT HE HAD BEEN INSTRUCTED BY THE DOCTOR TO USE HYDROQUINONE AND HE HAS BEEN USING IT FOR THE PAST 7 MONTHS. HOWEVER, HE STATED THAT THE LEFT HAND SIDE OF HIS FACE IS APPROXIMATELY TWO SHADES DARKER THAN THE SURROUNDING SKIN, WHILE THE TREATED AREA ON THE RIGHT SIDE IS APPROXIMATELY FIVE SHADES DARKER. WE HAVE BEEN TRYING TO CONTACT THE PHYSICIAN WHO PERFORMED THE PROCEDURE TO COLLECT ADDITIONAL INFORMATION HOWEVER, TO DATE WE HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321247 FRAXEL RE: STORE DUAL POWERED LASER SURGICAL INSTRUMENT GEX SOLTA MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1