BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERADOME

    MDR report key: 24604586 · Received March 16, 2026

    Report

    Report Number
    MW5185237
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 11, 2026
    Manufacturer
    THERADOME, INC
    Product Code
    OAP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GETTING MIGRAINES THAT I NEVER HAD BEFORE. I STOPPED USING THE THERADOME PRODUCT AND THE MIGRAINES WENT AWAY. THEY TOLD ME THEY REFUNDED ME FOR WHAT I PAID WHICH THEY NEVER DID. THE AMOUNT THEY OWE IS $693.51.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663377 THERADOME LASER, COMB, HAIR OAP THERADOME, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Disability MULTI.| THYROID MED.