BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVAPEN NXT

    MDR report key: 11737864 · Received April 27, 2021

    Report

    Report Number
    MW5101042
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 23, 2021
    Manufacturer
    REFINE USA, LLC
    Product Code
    QAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REFINE USA A MEDICAL DEVICE COMPANY IS AWARE THAT THERE IS A MAJOR MALFUNCTION WITH THEIR TIPS. THE MICRO-NEEDLING DEVICE IS NOT TREATING AT PROPER NEEDLE DEPTHS. THERE SHOULD BE A TOTAL RECALL OF THE CARTRIDGES, HOWEVER THE COMPANY IS NOT TAKING ANY PRECAUTION OR COMMUNICATING THE POSSIBILITY OF MALFUNCTION. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626706 REJUVAPEN NXT POWERED MICRONEEDLE DEVICE QAI REFINE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R