BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM MICRONEEDLES DERMA STAMP - DERMA ROLLER ALTERNATIVE -MICRONEEDLE MICRO

    MDR report key: 24521762 · Received March 5, 2026

    Report

    Report Number
    MW5184813
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 28, 2026
    Report Date
    February 28, 2026
    Manufacturer
    UNKNOWN
    Product Code
    GED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A NEW MICRO NEEDLE ON AMAZON. IT WAS SHIPPED AND SOLD BY AMAZON. THE PRODUCT CAME IN TWO PAPER PACKAGES, THE INTERNAL ONE HAD BEEN OPENED AND TAPED. INSIDE THE PAPER PACKAGES WAS A PLASTIC BAG WITH THE PRODUCT ITSELF. THE PHOTOS ADVERTISING THE PRODUCT SHOWED A BOX. BETWEEN THESE TWO RED FLAGS, I INSPECTED THE PRODUCT THROUGH THE PLASTIC BAG, AND NOTICED SCUFFS, AND IT APPEARS TO BE USED. THE PRODUCT IS STILL IN THAT BAG, UNOPENED BY ME. I CONTACTED AMAZON AND THEY PROVIDED A REFUND. MY LARGE CONCERN IS THAT THIS IS A MEDICAL DEVICE, I BELIEVE THIS SPECIFIC ONE IS NOT DIRECTLY REGULATED BY THE FDA, BUT BECAUSE OF THE TYPE OF PRODUCT I AM REPORTING IT HERE. THESE DEVICES CAN EASILY COME IN CONTACT WITH BLOOD AND SPREAD BLOODBORNE PATHOGENS. IF I HAD NOT CLOSELY INSPECTED THE ITEM AS I WAS UNPACKING IT, I COULD'VE EASILY MISSED THE FACT THAT IT WAS A USED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588833 TITANIUM MICRONEEDLES DERMA STAMP - DERMA ROLLER ALTERNATIVE -MICRONEEDLE MICRO BRUSH, DERMABRASION, MANUAL GED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown