BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW 3.0

    MDR report key: 15988068 · Received December 14, 2022

    Report

    Report Number
    MW5113822
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    December 13, 2022
    Report Date
    December 13, 2022
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE PURCHASED A WILLOW 3.0 BREAST PUMP. WITHIN 3 MONTHS ONE OF THE PUMPS STOPPED WORKING. A REPLACEMENT SET WAS SHIPPED TO US. WITHIN 3 MORE MONTHS, THOSE FAILED. THE COMPANY REFUSED TO REFUND US, OPTING INSTEAD TO SEND A SECOND REPLACEMENT SET (THIRD SET IN TOTAL). THAT NEW REPLACEMENT SET HAS NOT SHIPPED AS YET, AND THE CUSTOMER SERVICE REPRESENTATIVE SAYS THEIR SHIPPING DEPARTMENT IS BACKED UP, AND THEY DO NOT KNOW WHEN IT WILL SHIP. REVIEWING OTHER ONLINE CUSTOMER REVIEWS, IT SEEMS AS THOUGH THE TYPES OF SOFTWARE AND MECHANICAL FAILURES WE HAVE ENCOUNTERED ARE QUITE COMMON. AS THIS IS A REGULATED DEVICE, I IMPLORE WILLOW AND/OR FDA TO TAKE WHATEVER STEPS ARE NECESSARY TO CORRECT THESE MANUFACTURING FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2917910 WILLOW 3.0 PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC.
    2917911 WILLOW 3.0 PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC.
    2917912 WILLOW 3.0 PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female