BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYATION BREAST PUMP

    MDR report key: 18239195 · Received November 29, 2023

    Report

    Report Number
    MW5148586
    Event Type
    Malfunction
    Date Received
    November 29, 2023
    Date of Event
    October 1, 2022
    Report Date
    November 26, 2023
    Manufacturer
    BABYATION INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED THIS PUMP FOR OVER (B)(6) AND TRIED SEVERAL TIMES AND WOULD GET NO MILK, BUT WITH OTHER PUMPS, I WOULD GET PLENTY. I EVEN HAD FACETIME CALLS TO TRY TO GET THE PUMP TO WORK. STILL NEVER DID. DEFINITELY DECREASED MY MILK SUPPLY. AFTER SEVERAL WEEKS OF TRYING I HAD TO SWITCH TO ANOTHER PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430404 BABYATION BREAST PUMP PUMP, BREAST, POWERED HGX BABYATION INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female