BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10857107 · Received November 17, 2020

    Report

    Report Number
    3012759464-2020-00018
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    October 19, 2020
    Report Date
    November 17, 2020
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    UDI-DI
    00858298006293
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED AN INFECTION WHICH WAS TREATED BY A DOCTOR PRESCRIBED ORAL ANTIBIOTIC AND TOPICAL MEDICATION. A PRIMARY CAUSE OF INFECTION IS MILK STASIS WITHIN THE BREAST, PROVIDING A MEDIUM FOR BACTERIAL GROWTH. THERE ARE A VARIETY OF RISK FACTORS FOR INFECTION, INCLUDING MISSED OR RESTRICTED FEEDINGS, BREAST ENGORGEMENT, RESTRICTION FROM TIGHT BRA/ CLOTHING, PRONE SLEEPING POSITION, MATERNAL STRESS, EXCESSIVE FATIGUE, AND MALNUTRITION. THE WILLOW DEVICE HAS NOT YET BEEN EVALUATED BY EXPLORAMED NC7. 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 WEARABLE BREAST PUMP CAUSED OR CONTRIBUTED TO THE INCIDENCE OF INFECTION. WORLD HEALTH ORGANIZATION, MASTITIS CAUSES & MANAGEMENT, 2002. SPENCER JP, MANAGEMENT OF MASTITIS IN BREASTFEEDING WOMEN, AMERICAN FAMILY PHYSICIAN. 2008; 78 (6): 727-732. MICHIE C, THE CHALLENGE OF MASTITIS. ARCH DIS CHILD. 2003: 88, 818-821. FOXMAN B, LACTATION MASTITIS: OCCURRENCE AND MEDICAL MANAGEMENT AMONG 946 BREASTFEEDING WOMEN IN THE UNITED STATES. AM J EPIDEMIOL, 155 (2) 2002.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER AND SISTER REPORTED TO (B)(6) CUSTOMER CARE ON 19 OCT 2020 THAT THE CUSTOMER HAD BEEN DIAGNOSED WITH AN INFECTION OF THE NIPPLE. THE CUSTOMER VISITED THE HOSPITAL AND WAS PRESCRIBED ORAL ANTIBIOTICS AND TOPICAL CREAM (MEDICATION DETAILS NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320937 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW29 00858298006293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention