BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOMCOZY BREAST PUMP

    MDR report key: 20577694 · Received October 30, 2024

    Report

    Report Number
    MW5161929
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Report Date
    October 28, 2024
    Manufacturer
    GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO INFORM THE FDA THAT SHE ORDERED A MOMCOZY BREAST PUMP FROM AMAZON.COM. WHEN THE PUMP ARRIVED, THERE WAS NOTICEABLE TAMPERING OF THE DEVICE WHICH INDICATED PREVIOUS USE THAT INCLUDED: TORN PACKAGING OF ALL COMPONENTS, FINGERPRINTS AND SMUDGES ON THE DEVICE FLANGES, HAIR ON THE DEVICE, DRIED BREAST MILK RESIDUE AND INDICATIONS OF BACTERIAL GROWTH. REPORTER CONTACTED THE MANUFACTURER AND SUBSEQUENTLY, HAD THE DEVICE REPLACED WITH A NEW AND UNUSED BREAST PUMP. CALLER WANTED TO REPORT THIS INCIDENT AS IT IS A PUBLIC HEALTH ISSUE THAT SELLERS ARE NOT PROPERLY EXAMINING OR UNDERTAKING QUALITY CONTROL OF RETURNED PRODUCTS THAT CAN RESULT IN SERIOUS HEALTH CONSEQUENCES FOR CONSUMERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034226 MOMCOZY BREAST PUMP PUMP, BREAST, POWERED HGX GUANGDONG YOUMENG ELECTRICAL TECHNOLOGY CO., LTD. P065424072030003

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female