BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYMA LASER

    MDR report key: 22943367 · Received September 2, 2025

    Report

    Report Number
    MW5175513
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 1, 2025
    Report Date
    August 27, 2025
    Manufacturer
    LYMA LIFE, LTD
    Product Code
    OHS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    LYMA LASER CONTRIBUTED TO MAST CELL DEGRANULATION IN A MAST CELL ACTIVATION SYNDROME PATIENT. CAUSED ACUTE PSYCHOLOGICAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2450310 LYMA LASER LIGHT BASED OVER THE COUNTER WRINKLE REDUCTION OHS LYMA LIFE, LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention ARMOUR THYROID.| ZOLOFT.