BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYATION BREAST PUMP

    MDR report key: 20463295 · Received October 15, 2024

    Report

    Report Number
    MW5161098
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Report Date
    October 10, 2024
    Manufacturer
    BABYATION INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE BREAST PUMP DOES NOT WORK AS ADVERTISED. THERE IS NO SUCTION TO REMOVE MILK AS ADVERTISED, DESPITE WORKING WITH CUSTOMER SERVICE TO TROUBLESHOOT THE DEVICE. THE ADVERTISING IS INCREDIBLY MISLEADING AND CUSTOMERS ARE WASTING (B)(6) WITH NO ABILITY TO RETURN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286780 BABYATION BREAST PUMP PUMP, BREAST, POWERED HGX BABYATION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female