BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW 3.0 BREAST PUMP

    MDR report key: 17755537 · Received September 14, 2023

    Report

    Report Number
    MW5145672
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 12, 2023
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WILLOW BREAST PUMP HAVE INCORRECT OUTPUT OF DATA AS TO THE AMOUNT PUMPED. NOT ADEQUATE SUCTION DESPITE DIFFERENT SIZES, CAUSING PUMP TO NOT WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294141 WILLOW 3.0 BREAST PUMP PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC. WILLOW 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other