BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRONEEDLING DEVICE

    MDR report key: 7079170 · Received December 1, 2017

    Report

    Report Number
    MW5073723
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    November 21, 2017
    Report Date
    November 30, 2017
    Manufacturer
    UNK
    Product Code
    GEY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD MICRO NEEDLING DONE TO MY FOREHEAD AND FACE. AFTER THE PROCEDURE I HAD A SEVERE HEADACHE POUNDING. I COULDN'T WORK AND A WEEK LATER AM STILL IN PAIN. I WENT TO MY DOCTOR AND SHE SAID IT MOST LIKELY WAS AN ADVERSE REACTION TO MICRONEEDLING. I AM STILL IN SO MUCH PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854042 MICRONEEDLING DEVICE MICRO NEEDLE FOR GENERAL S/ PLASTIC GEY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention