BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 11313564 · Received February 10, 2021

    Report

    Report Number
    MW5099347
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 9, 2021
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A BREAST PUMP FROM (B)(4) ONLINE AND THE MANUFACTURER IS WILLOW (HTTPS://WILLOWPUMP.COM/). I OPENED WHAT I BELIEVED WAS A SEALED KIT, BUT AFTER CONNECTING IT TO THE SMARTPHONE APP, I FIND HISTORICAL USER DATA PRIOR TO WHEN I PURCHASED THE UNIT. I CONTACTED WILLOW TO SEE IF THERE WAS A SOFTWARE BUG, AND THEIR APPLICATION DEVELOPMENT TEAM WAS UNABLE TO DETERMINE THE ISSUE. I HAVE ASKED WILLOW SEVERAL TIMES IF THE UNIT HAS EVER BEEN USED AND FOR EVIDENCE THAT THE SERIAL NUMBERS I PURCHASED WERE INDEED BRAND NEW, THEY HAVE NOT BEEN ABLE TO CONFIRM OR SHOW PROOF. I HAVE ASKED WILLOW FOR A REFUND AND THEY HAVE DENIED MY REQUEST. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208362 WILLOW WEARABLE BREAST PUMP PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC. WILLOW® WEARABLE BREAST PUMP GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR