BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW 3.0 BREAST MILK CONTAINER

    MDR report key: 17173247 · Received June 21, 2023

    Report

    Report Number
    3012759464-2023-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 21, 2023
    Manufacturer
    WILLOW INNOVATIONS, INC.
    Product Code
    HGX
    PMA / PMN Number
    K191577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT MAGNETS HAD FALLEN OUT OF HER WILLOW 3.0 BREAST MILK CONTAINERS, WITH ONE OF THE MAGNETS UNRECOVERED. PREVIOUSLY, ON (B)(6) 2023, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT A MAGNET FROM HER REUSABLE MILK CONTAINER CAME OFF AND THE CONTAINER WAS NOT RECOGNIZED BY THE PUMP. CUSTOMER HAS BEEN GIVEN REPLACEMENT CONTAINERS AND PUMPS. CUSTOMER HAS NOT SHARED HER CLEANING METHOD, CONTAINERS HAVE NOT BEEN RETURNED AND LOT NUMBERS HAVE NOT BEEN REPORTED. A MANUFACTURING REVIEW WAS CONDUCTED ON THE PUMP DEVICE HISTORY RECORD AND NO NONCONFORMANCES WERE NOTED IN THE PRODUCTION OF THE PUMPS THAT MATED WITH THE CONTAINERS. SINCE COMMERCIALIZATION OF THE WILLOW 3.0 BREAST MILK CONTAINER IN 2019, TREND ANALYSIS REVEALS THAT THERE HAS BEEN ONLY 1 OTHER REPORTED INCIDENCE OF A MAGNET FALLING OUT OF THE MILK CONTAINER DURING USE. WE WILL CONTINUE TO MONITOR TRENDS FOR THIS FAILURE MODE. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DEFINITIVELY CONCLUDED THAT A DEFECT IN THE MILK CONTAINER CAUSED OR CONTRIBUTED TO MAGNETS COMING OUT OF THE CONTAINER.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER REPORTED THAT THE MAGNETS OF HER REUSABLE MILK CONTAINERS HAD FALLEN OFF, WITH ONE MAGNET ENDING UP IN THE POT SHE USED FOR STERILIZING AND, SUBSEQUENTLY, IN HER FOOD. THE OTHER MAGNET FROM HER CONTAINER IS REPORTEDLY MISSING.MEDWATCH REPORT (B)(4) CORRESPONDING TO THIS ISSUE WAS RECEIVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823251 WILLOW 3.0 BREAST MILK CONTAINER REUSABLE MILK CONTAINER FOR POWERED BREAST PUMP (WILLOW 3.0) HGX WILLOW INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female