BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZ INJECT THREE PRONG NEEDLE

    MDR report key: 24931401 · Received April 20, 2026

    Report

    Report Number
    MW5187000
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    April 4, 2026
    Report Date
    April 15, 2026
    Manufacturer
    COSMOFRANCE
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE 3 NEEDLE DEVICE MALFUNCTIONED WHEN FILLED WITH PRF DURING A HAIR RESTORATION TREATMENT. WHEN NURSE WAS PUSHING THE BLOOD THROUGH INTO THE CROWN OF THE SCALP, THE NEEDLE CAME OFF AND PATIENTS PRF BLEW BACK IN NURSES FACE AND EYE. NEEDLE WAS A EZ INJECT THREE PRONG NEEDLE BY (B)(4). NEEDLE WAS PART OF LOT NUMBER 202506 WITH AN EXP DATE OF 2028-06.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995012 EZ INJECT THREE PRONG NEEDLE NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA COSMOFRANCE EZ INJECT-05 202506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female