BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERADOME EVO LASER HAIR GROWTH DEVICE

    MDR report key: 12136465 · Received July 7, 2021

    Report

    Report Number
    MW5102361
    Event Type
    Injury
    Date Received
    July 7, 2021
    Date of Event
    July 30, 2020
    Report Date
    July 3, 2021
    Manufacturer
    THERADOME, INC.
    Product Code
    OAP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THERADOME EVO LASER HAIR GROWTH DEVICE FOR 10 SESSIONS FOR A TOTAL OF 2.5 WEEKS. I STOPPED BECAUSE I HAD HEADACHES AFTER USING THE DEVICE AND MY HAIR ROOTS WOULD STING IN MY SCALP. UPON USING THE DEVICE I LOST 50% OF MY HAIR AND HAVE BALD LINES WHERE I PARTED MY HAIR TO RECEIVE TREATMENT BASED ON THE DEVICE INSTRUCTIONS. DURING THE FIRST WEEK, I REFERRED TO THE WEBSITE, AND IT SAID IT'S PART OF THE PROCESS OF NEW HAIR PUSHING OUT THE OLD HAIR, SO I CONTINUED WITH THE TREATMENT. BUT I NOTICED THAT EVEN NEW SHORT HAIRS WERE STILL FALLING OUT. EVENTUALLY, DUE TO THE PAIN I STOPPED, BUT AFTER WAITING FOR A YEAR THE HAIR HAS NOT GROWN BACK, OR IF IT HAS IT IS VERY THIN AND THE BALD LINES ARE VERY VISIBLE. I GOT A SCALP BIOPSY 3 MONTHS AGO AS WELL, AND IT DID NOT INDICATE THAT THE HAIR WAS GOING THROUGH TELOGEN EFFLUVIUM. IT SAID IT LOOKED LIKE ANDROGENIC ALOPECIA, BUT CONCENTRATED AT THE THERADOME BALD LINES INSTEAD OF THE USUAL LOCATIONS WHERE ANDROGENIC ALOPECIA OCCURS. I AM NOW GOING TO TRY PRP TO RESTORE THE HAIR THAT I LOST USING THAT DEVICE. IT HAS BEEN VERY DEPRESSING FOR ME. (ALSO, THE DATES I HAVE INDICATED THE PROBLEM OCCURRED IS APPROXIMATE +/- 2 TO 4 WEEKS. ALTHOUGH THE DURATIONS I MENTIONED ARE EXACT.) FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022939 THERADOME EVO LASER HAIR GROWTH DEVICE LASER, COMB, HAIR OAP THERADOME, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention