BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLOV MICROINFUSION SYSTEM

    MDR report key: 21060736 · Received January 2, 2025

    Report

    Report Number
    MW5164210
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 19, 2024
    Report Date
    December 23, 2024
    Manufacturer
    UNKNOWN
    Product Code
    GED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT DOES NOT WORK. IT IS A MANUAL MICRONEEDLING DEVICE THAT DELIVERS SODIUM HYALURONATE. THE NEEDLES DO NOT WORK. NOTHING IS DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431568 GLOV MICROINFUSION SYSTEM BRUSH, DERMABRASION, MANUAL GED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown