BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER CAP 272

    MDR report key: 21687510 · Received March 25, 2025

    Report

    Report Number
    MW5168110
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    November 11, 2022
    Report Date
    March 20, 2025
    Manufacturer
    LEXINGTON INTERNATIONAL LLC.
    Product Code
    OAP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    CUSTOMER CLAIMS CONTROLLER SET FIRE/SMOKE WHEN TURNING THE DEVICE ON PER CUSTOMER REPORT DAMAGES TO HER PROPERTY. OPEN INVESTIGATION INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114109 LASER CAP 272 LASER, COMB, HAIR OAP LEXINGTON INTERNATIONAL LLC. LASER CAP 272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other