BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYATION BREAST PUMP

    MDR report key: 17451582 · Received August 2, 2023

    Report

    Report Number
    MW5120514
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 1, 2023
    Report Date
    August 2, 2023
    Manufacturer
    BABYATION INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED WITH COMPLAINT THAT THE BABYATION BREAST PUMP DOES NOT WORK. WHEN USING THE DEVICE TO EXPRESS MILK, THE PUMP CONSISTENTLY CLOGS UP IN THE FLANGE AND SUBSEQUENTLY OVERFILLS/OVERFLOWS WHICH IN TURN SPILLS OUT THE MILK. THE MILK IS UNABLE TO BE STORED. REPORTER STATES THAT THE COMPANY WILL NOT REIMBURSE HER FOR THE DEFECTIVE DEVICE. REPORTER HAS SPOKEN TO OTHER NEW MOTHERS, AS WELL AS RESEARCHED BLOGS, AND SAID THE SAME THING IS HAPPENING TO THEM AS WELL WITH THE BABYATION BREAST PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772344 BABYATION BREAST PUMP PUMP, BREAST, POWERED HGX BABYATION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female