BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DR PEN USA MICRONEEDLING DEVICE

    MDR report key: 12188910 · Received July 16, 2021

    Report

    Report Number
    MW5102615
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    July 14, 2021
    Report Date
    July 14, 2021
    Manufacturer
    GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.
    Product Code
    QAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFECTION; DR PEN SELLS ONLINE (B)(6) BUT ALSO ON(B)(6) AS A MICRONEEDLING DEVICE BUT NO FDA APPROVAL, YET STATES THAT IT CAN HELP WITH WRINKLES, ANTI AGING, HAIR, THINNING LAX SKIN, STRETCH MARKS, ACNE MARKS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082277 DR PEN USA MICRONEEDLING DEVICE POWERED MICRONEEDLE DEVICE QAI GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD. A8, A6, A6S, A7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other