BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERADOME PRO HAIR LOSS HELMET

    MDR report key: 24662611 · Received March 23, 2026

    Report

    Report Number
    MW5185568
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 13, 2026
    Manufacturer
    THERADOME, INC.
    Product Code
    OAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING THE THERADOME HAIR GROWTH HELMET FOR A FEW MONTHS AND STARTED GETTING MIGRAINES. WHEN I STOPPED USING IT IN (B)(6) 2026, THE MIGRAINES STOPPED. I REPORTED THIS TO THE COMPANY ON THEIR TOLL-FREE NUMBER (B)(6). I WAS TOLD TO RETURN THE HELMET AND THEY WOULD ISSUE ME A REFUND. I DID RETURN THE HELMET AND THEY SENT ME AN EMAIL THAT I WOULD RECEIVE A REFUND. THE EMAIL IS DATED (B)(6) 2026 AND STATES THAT THE REFUND WOULD COME WITHIN ONE BUSINESS DAY. IT NEVER HAPPENED. NOR DID THEY ADDRESS THE PROBLEM OF MY MIGRAINES WHICH I HAVEN'T HAD SINCE I STOPPED USING THE HELMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719943 THERADOME PRO HAIR LOSS HELMET LASER, COMB, HAIR OAP THERADOME, INC. PPO

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other "MULTI"| ROSUVATATIN 10 MG| SYNTHROID 50 MCG