BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WILLOW REUSABLE CONTAINERS

    MDR report key: 17031614 · Received May 30, 2023

    Report

    Report Number
    MW5117992
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 25, 2023
    Report Date
    May 25, 2023
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELLO, I AM A PHYSICIAN AND A MOTHER AND I CURRENTLY USE THE WILLOW 3.0 BREAST PUMP WITH REUSABLE CONTAINER. I STERILIZE THE CONTAINERS AS DIRECTED IN THEIR USER MANUAL. THE CONTAINERS CONNECT WITH PUMP THROUGH MAGNETS. WITHIN THE LAST 2 MONTHS IT HAS HAPPENED 3 TIMES THAT THE MAGNETS HAVE COME OFF. IT HAS HAPPENED TWICE THAT THE MAGNETS WERE IN THE STERILIZING POT AND ONE TIME I FOUND THE MAGNET IN MY MOUTH MIXED IN FOOD THAT WAS PREPARED IN THAT POT FOR BOTH MYSELF AND MY INFANT. THE LAST TIME I WAS NOT ABLE TO FIND THE MAGNET AND I'M CONCERNED IT MIGHT HAVE ENDED UP BEING SWALLOWED BY MY INFANT. IT SEEMS THE COMPANY HAS AN ADHESIVE ISSUE. BESIDES THAT IT IS A CHOKING HAZARD, IT ALSO CAN CREATE A LIFE THREATENING ISSUE OF MAGNETS CONNECTING IN THE BOWEL AND CREATING PSEUDO ANASTOMOSES. THE COMPANY HAS BEEN VERY POOR IN THEIR RESPONSE AND I WOULD LIKE TO WARN THE FDA TO PREVENT ANY ACCIDENTS HAPPENING WITH OTHER USERS OR THEIR INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329004 WILLOW REUSABLE CONTAINERS PUMP, BREAST, POWERED HGX WILLOW INNOVATIONS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other