BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DR PEN A6S

    MDR report key: 17923566 · Received October 11, 2023

    Report

    Report Number
    MW5146847
    Event Type
    Injury
    Date Received
    October 11, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 5, 2023
    Manufacturer
    GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.
    Product Code
    QAI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I RECENTLY PURCHASED A MICRO NEEDLING DEVICE DR PEN A6S FROM THE INTERNET. DURING THE PURCHASE PROCESS I WAS EXPECTING TO PROVIDE PROOF OF LICENSE OR QUALIFICATION PRIOR TO PURCHASING, BUT WAS NOT ASKED. WHEN I RECEIVED THE DEVICE, I READ THE USER GUIDE BEFORE ASSEMBLING THE PEN. UPON OPENING THE PACKAGE THAT CONTAINED THE MICRO NEEDLING TIP AND PERFORMING THE ALCOHOL STERILIZATION REQUIRED AS PER INSTRUCTED, I NOTICED THAT THERE SEEMED TO BE NO APPARENT SEAL WITHIN THE NEEDLE CARTRIDGE. I KNOW FROM EXPERIENCE, THESE TYPES OF CARTRIDGES MUST CONTAIN A SEAL TO PREVENT BODILY FLUIDS PASSING INTO THE DEVICE. TO TEST THIS I ADDED WATER TO THE CARTRIDGE FROM THE TIP END AND FOUND THAT IT DRIPPED DOWN THE STEM OF TIP THAT INSERTED INTO THE DEVICE ITSELF. THERE WERE SEVERAL DIFFERENT TYPES OF NEEDLE TIPS SO I TRIED EACH ONE. EACH RESULTED IN THE SAME RESULT. OBVIOUSLY, THIS IS A HUGE CONCERN TO ME AS THIS COULD POTENTIALLY LEAD TO CROSS CONTAMINATION FROM PATIENT TO PATIENT. SINCE THIS APPEARS TO BE AN FDA CLEARED DEVICE I AM CONCERNED THAT THE AGENCY HAVE OVERLOOKED THIS IMPORTANT SAFETY FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908379 DR PEN A6S POWERED MICRONEEDLE DEVICE QAI GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD. DR PENA6S US D0302

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention