BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 12953622 · Received December 6, 2021

    Report

    Report Number
    MW5105861
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    December 2, 2021
    Report Date
    December 2, 2021
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED A WEARABLE WILLOW SERIES 3 BREAST PUMP AND HAVE HAD MANY ISSUES USING IT OVER THE PAST FEW MONTHS. GETTING IT TO START ON THE FIRST TIME HAPPENS LESS THAN 5% OF THE TIME, AND I HAVE TO RETRY MY CONNECTION 4-10 TIMES EVERY DAY. THE APP DISPLAYS INFORMATION THAT I NEED TO RECONNECT ONE OF THE COMPONENTS EVERY TIME, AND IT SEEMS LIKE THERE'S NO RHYME OR REASON FOR WHY IT KEEPS GIVING ME ERRORS. THE AMOUNT OF MILK IT REPORTS I PRODUCE IS NOT VERY ACCURATE. RECENTLY IT SAID I PUMPED 25 OZ ON ONE SIDE, WHEN THE CAPACITY IS 5 OZ. THERE ARE ALSO SESSIONS THAT DON'T REGISTER. OVER TIME THE NOISE THE PUMP MAKES INCREASES. I CALL REPEATEDLY AND THEY SAY THE DON'T HAVE RECORDS OF MY PREVIOUS COMPLAINTS. WHEN I CALL, THEY WILL SEND ME ONE OF THE FIVE COMPONENTS WHEN I BELIEVE THEY SHOULD SEND ME AN ENTIRE REPLACEMENT RATHER THAN PIECEMEAL THINGS TOGETHER. MY CONCERN WITH THIS IS I NEED TO USE IT AT WORK. WITH THESE ISSUES, I RUN THE RISK OF NOT BEING ABLE TO EXPEL MY MILK, OR WORST CASE MIGHT NOT BE ABLE TO FEED MY CHILD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843325 WILLOW WEARABLE BREAST PUMP PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female ESCITALOPRAM| PRENATAL VITAMIN | RIZATRIPTAN | SYNTHROID| VITAMIN D