BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REGROW MD HAIRMAX LASER 272

    MDR report key: 8394149 · Received March 5, 2019

    Report

    Report Number
    MW5084668
    Event Type
    Injury
    Date Received
    March 5, 2019
    Date of Event
    November 5, 2018
    Report Date
    March 2, 2019
    Manufacturer
    LEXINGTON INTL, LLC
    Product Code
    OAP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED USING REGROW LASER CAP BY HAIRMAX WITH LASER 272 IN (B)(6) 2018 TO IMPROVE HAIR GROWTH BECAUSE I HAVE FEMALE PATTERN HAIR LOSS. I HAVE NOT SEEN ANY OF THE PROMISED BENEFITS, NOT EVEN A PROGRESS IN THAT DIRECTION AND ONLY SIDE EFFECTS SO FAR FOR 4 MONTHS. THE WORST SIDE EFFECTS ARE ITCHY, OILY, FLAKY SCALP AND POSSIBLY ASSOCIATED SHEDDING OF TINY HAIRS, WITH NO SIGNS OF IMPROVEMENT SO FAR. EVEN THOUGH HAIR SHEDDING IS A WELL-KNOWN OF ANY HAIR GROWTH TREATMENT, IT IS NOT ADDED AS A SIDE EFFECT IN THE USER MANUAL OR THE DEVICE BOX. FDA HAS NOT ASKED THEM TOO EITHER, STRANGE. THIS HAS SEVERELY IMPACTED MY HAIR QUALITY AND OVERALL PSYCHE. MORE IMPORTANCE HAS TO BE GIVEN TO THIS AND FDA HAS TO INTERVENE BECAUSE THIS DEVICE IS REGULATED BY FDA AS CLASS II.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186440 REGROW MD HAIRMAX LASER 272 LASER, COMB, HAIR OAP LEXINGTON INTL, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other