BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 18871864 · Received March 9, 2024

    Report

    Report Number
    3012759464-2024-00001
    Event Type
    Injury
    Date Received
    March 9, 2024
    Date of Event
    January 2, 2024
    Report Date
    March 9, 2024
    Manufacturer
    WILLOW INNOVATIONS, INC.
    Product Code
    HGX
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WILLOW HAS REQUESTED THE PUMPS BACK FROM CUSTOMER BUT HAS NOT YET RECEIVED THEM. CUSTOMER HAS REQUESTED REPLACEMENT PUMPS. NEW SIZING INSERTS WERE ALSO SENT TO IMPROVE COMFORT AND OUTPUT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD CLOGGED DUCTS AND SWOLLEN NIPPLES FROM USING THE WILLOW PUMP. SHE ALSO HAD AN ABSCESS IN HER RIGHT BREAST AND WAS GOING TO THE DOCTOR. CUSTOMER WAS PRESCRIBED CLINDAMYSIN AND WAS USING A WALL PUMP UNTIL THE ABSCESS IS HEALED. AS OF ON (B)(6) 2024, CUSTOMER REPORTED THAT THE ABSCESS IN HER RIGHT BREAST WAS DRAINED OUT AND HAS GONE DOWN/HEALED. HER DOCTOR ADVISED THAT SHE NEEDS TO COMPLETELY EMPTY AND SHE CONTINUES TO USE HER WALL PUMP WHILE HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660956 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX WILLOW INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention