BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE PUMP

    MDR report key: 16067663 · Received December 27, 2022

    Report

    Report Number
    MW5114048
    Event Type
    Malfunction
    Date Received
    December 27, 2022
    Date of Event
    November 15, 2022
    Report Date
    December 22, 2022
    Manufacturer
    BABYATION, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS IN REGARDS TO THE BABYATION BREAST PUMP. I ORDERED THE PUMP ON (B)(6) 2022 AND RECEIVED IT SEVERAL WEEKS LATER. AFTER ONE USE, THE SUCTION STOPPED WORKING. I CONTACTED THE COMPANY AND THEY GOT ON A VIDEO CALL TO TROUBLESHOOT WITH ME. ONE OF THE "POSTS" MALFUNCTIONED AND THEY AGREED TO SEND ME A NEW ONE. I GOT THE NEW POST, USED THE PUMP AGAIN AND HAD THE SAME ISSUE. I CONTACTED THEM AGAIN AND THEY ASKED ME TO SEND THE PUMP BACK. AFTER ANOTHER WEEK OR SO THEY SAID THEY WOULD SEND ME A REPLACEMENT PUMP. I'VE ASKED FOR A REFUND MULTIPLE TIMES AND THEY'VE DENIED IT SAYING IT'S A MEDICAL DEVICE. I WANT TO FLAG FOR THE FDA BECAUSE I DON'T THINK THIS COMPANY SHOULD CONTINUE TO BE ABLE TO PUSH AN INEFFECTIVE AND FINICKY PRODUCT AND THEN REFUSE TO REFUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239833 THE PUMP PUMP, BREAST, POWERED HGX BABYATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female ELVIE BREAST PUMP| IRON| POSTNATAL VITAMINS| VITAMIN D| ZOLOFT