BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW PUMP

    MDR report key: 13257986 · Received January 13, 2022

    Report

    Report Number
    MW5106667
    Event Type
    Malfunction
    Date Received
    January 13, 2022
    Date of Event
    August 1, 2021
    Report Date
    January 11, 2022
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WILLOW BREAST PUMP DOES NOT WORK. IT IS HEAVILY MARKETED ON (B)(4) AND OTHER SOCIAL MEDIA AND THERE ARE TONS OF COMPLAINTS ON PRIVATE(B)(6) PAGES. IT CONSISTENTLY REFLECTS MATERIALLY HIGHER VOLUME THAN IS ACTUALLY PRODUCED, VARIOUS FEATURES BREAK OR MALFUNCTION - SOMETIMES INJURING USERS NIPPLES. FDA SAFETY REPORT ID#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122670 WILLOW PUMP PUMP, BREAST, POWERED HGX EXPLORAMED NC7, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female