BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRISTAR ONE- PHOTONS SYSTEM

    MDR report key: 8857086 · Received July 31, 2019

    Report

    Report Number
    MW5088700
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 24, 2019
    Report Date
    July 29, 2019
    Manufacturer
    TRISTAR ONE
    Product Code
    NHN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING AN LED LIGHT THERAPY DEVICE PURCHASED ON (B)(6), I HAVE DEVELOPED A SEVERE RASH REQUIRING CORTISONE TREATMENT. IT HAS ALSO TRIGGERED MY ASTHMA WHICH HAS ALSO REQUIRED TREATMENT WITH A STEROID. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2019. DATE THE PERSON STOPPED TAKING OR USING THE PRODUCT: (B)(6) 2019. WHY WAS THE PERSON USING THE PRODUCT? TREATING SUN DAMAGE ON ARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638795 TRISTAR ONE- PHOTONS SYSTEM POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING AFFECT FOR ADJ NHN TRISTAR ONE

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR