BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYATION BREAST PUMP

    MDR report key: 17443053 · Received August 1, 2023

    Report

    Report Number
    MW5120484
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 29, 2023
    Manufacturer
    BABYATION INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS PRODUCT HAS BEEN MARKETED AS A REVOLUTIONARY BREAST PUMP, HOWEVER, IT DOES NOT WORK. I AM A LACTATING/BREASTFEEDING MOTHER WITH EXCELLENT MILK SUPPLY AND USING OTHER BREAST PUMPS SUCCESSFULLY. I HAVE BEEN GATHERING EXPERIENCES OF OTHER USERS AND CANNOT FIND A SINGLE USER WHO WAS ABLE TO USE IT SUCCESSFULLY. THE COMPANY ALSO APPEARS TO REFUSE TO ISSUE REFUNDS. THIS IS AN EXAMPLE SIMILAR TO THE THERANOS CASE. A NEW/REVOLUTIONARY PRODUCT DESIGN BUT WITH CLEAR FAILURE AND A REFUSAL TO RECOGNIZE THE DEFECT AND DISCONTINUE SALES. THIS IS PREDATORY TO NEW MOTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457630 BABYATION BREAST PUMP PUMP, BREAST, POWERED HGX BABYATION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female