BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTOUCH CT3PZ

    MDR report key: 4947094 · Received July 22, 2015

    Report

    Report Number
    2951571-2015-00001
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 23, 2015
    Report Date
    July 22, 2015
    Manufacturer
    NEW STAR LASERS, INC. DBA COOLTOUCH INC.
    Product Code
    GEX
    PMA / PMN Number
    K101783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ACNE TREATMENT, THE PATIENT EXPERIENCED A RED SCAR OF APPROX. 1 CM ON THE FOREHEAD. THE PATIENT WAS INSTRUCTED TO APPLY OVER-THE-COUNTER HYDROCORTISONE TOPICAL OINTMENT TO THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474262 COOLTOUCH CT3PZ GEX NEW STAR LASERS, INC. DBA COOLTOUCH INC. CT3PZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention