BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER HAIR GROWTH CAP

    MDR report key: 21470951 · Received February 26, 2025

    Report

    Report Number
    MW5166869
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    February 1, 2025
    Report Date
    February 22, 2025
    Manufacturer
    UNKNOWN
    Product Code
    OAP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A RED-LIGHT HAIR GROWTH DEVICE ON AMAZON AND INSTEAD OF DOING ANYTHING, IT BURNED MY SCALP! THIS AMAZON SELLER FROM CHINA USED ILLEGAL MEANS TO APPLY THE 510K FILE FROM THE OFFICIAL WEBSITE TO SELL COUNTERFEITS, AND A LOT OF PEOPLE WERE CHEATED AND EVEN HURT 510(K) NUMBER: K192627. (B)(6). LASER HAIR GROWTH CAP IS LOW LEVEL LASER THERAPY (LLLT) DEVICES THAT PROMOTE HAIR GROWTH IN WOMEN AND MENLASER HAIR GROWTH CAP. REFER TO ADDITIONAL DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027340 LASER HAIR GROWTH CAP LASER, COMB, HAIR OAP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male Required Intervention