BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10193216 · Received June 24, 2020

    Report

    Report Number
    3012759464-2020-00004
    Event Type
    Injury
    Date Received
    June 24, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 24, 2020
    Manufacturer
    EXPLORAMED NC7, INC
    Product Code
    HGX
    UDI-DI
    00858298006446
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED BREAST IRRITATION WHICH WAS TREATED WITH ORAL ANTIBIOTICS. THE WILLOW DEVICE WAS NOT RETURNED TO EXPLORAMED NC7 FOR EVALUATION, AS THE CUSTOMER CONTINUES TO PUMP WITH WILLOW. HOWEVER, A MANUFACTURING REVIEW WAS CONDUCTED ON THE DEVICE HISTORY RECORD AND NO NONCONFORMANCES WERE NOTED IN THE PRODUCTION OF THIS DEVICE. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE WILLOW BREAST PUMP CAUSED OR CONTRIBUTED TO THE INCIDENCE OF IRRITATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(6) 2020 THAT SHE EXPERIENCED EXTREME DISCOMFORT AND EXCESSIVE PINCHING WHEN USING WILLOW CONTAINERS. CUSTOMER SOUGHT MEDICAL ADVICE FIRST VIA TELEPHONE, DUE TO COVID 19, AND WAS FIRST PRESCRIBED A COMPOUNDED OINTMENT, THEN ANTIBIOTICS. AFTER A WEEK OF NO RELIEF, SHE VISITED THE DOCTOR'S OFFICE AND WAS TOLD SHE HAD IRRITATION DUE TO THE PUMP. THE CUSTOMER CONTINUED TO PUMP WITH WILLOW BOTH DURING AND AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656837 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention