BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER DEVICE

    MDR report key: 21701134 · Received March 26, 2025

    Report

    Report Number
    MW5168282
    Event Type
    Injury
    Date Received
    March 26, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 23, 2025
    Manufacturer
    ERCHONIA CORPORATION
    Product Code
    NHN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ERCHONIA EVRL LASER DEVICE (LOW LEVEL LASER THERAPY) AT (B)(6) BLEACHED MY FINGERS WITH PALE (COOKED) SCARS AFTER 20 MINUTES OF EMISSION OF LASER ON MY FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041684 LASER DEVICE POWERED LIGHT BASED LASER NON-THERMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJ NHN ERCHONIA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention| O