BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVAPEN NXT

    MDR report key: 14359136 · Received May 10, 2022

    Report

    Report Number
    MW5109631
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 9, 2022
    Manufacturer
    REFINE USA, LLC.
    Product Code
    QAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    117
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I WAS DOING A MICRO-NEEDLING TREATMENT ON THE PATIENT, WHEN THE NEEDLES STABBED THE PATIENT IN THE FACE BEYOND THE INTENDED DEPTH. THERE WAS NO WARNING, THE CLIENT NEARLY JUMPED OFF THE TABLE AND BEGAN BLEEDING IN THE AREA WHERE THE INCIDENT HAPPENED. I REPLACED THE NEEDLE CARTRIDGE AND TESTED IT AND AGAIN THE NEEDLE WAS NOT TREATING PROPERLY. THIS IS A SERIOUS DANGER AS IT COULD CAUSE SEVER DAMAGE IN AREAS WITH BLOOD VESSELS. IN SPEAKING WITH OTHER PROVIDERS THIS IS A KNOWN ISSUE WITH THIS DEVICE AND SHOULD BE ADDRESSED IMMEDIATELY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872046 REJUVAPEN NXT POWERED MICRONEEDLE DEVICE QAI REFINE USA, LLC. NXT

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other| R