BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10324181 · Received July 24, 2020

    Report

    Report Number
    3012759464-2020-00009
    Event Type
    Injury
    Date Received
    July 24, 2020
    Date of Event
    May 15, 2020
    Report Date
    July 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 MASTITIS WHICH WAS TREATED BY PRESCRIBED ANTIBIOTICS. A PRIMARY CAUSE OF MASTITIS IS MILK STASIS WITHIN THE BREAST, PROVIDING A MEDIUM FOR BACTERIAL GROWTH. THERE ARE A VARIETY OF RISK FACTORS FOR MASTITIS, INCLUDING MISSED OR RESTRICTED FEEDINGS, BREAST ENGORGEMENT, RESTRICTION FROM TIGHT BRA/ CLOTHING, PRONE SLEEPING POSITION, MATERNAL STRESS, EXCESSIVE FATIGUE, AND MALNUTRITION. MASTITIS IS USUALLY A BENIGN, SELF-LIMITING CONDITION, WITH FEW CONSEQUENCES TO THE INFANT AND INCIDENCE RANGING FROM 4-27%. BLISTERS ON THE NIPPLE/ BREAST CAN BE CAUSED BY FREQUENT BREASTFEEDING WITH FRICTION DUE TO IMPROPER LATCH, IMPROPER SIZING OF THE FLANGE, OR MALALIGNMENT WITHIN THE FLANGE. THE WILLOW DEVICE HAS NOT YET BEEN RETURNED TO EXPLORAMED NC7 FOR EVALUATION. 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 INCIDENT OF MASTITIS AND BLISTER. 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. WAMBACH, KAREN, AND JAN RIORDAN. BREASTFEEDING AND HUMAN LACTATION. 5TH ED., JONES & BARTLETT LEARNING, 2016. BERENS P, ABM CLINICAL PROTOCOL# 26: PERSISTENT PAIN WITH BREASTFEEDING. BREASTFEED MED., 2016;11(2):46-53.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO (B)(6) CUSTOMER CARE ON 24 JUN 2020 THAT SHE HAD GONE TO THE HOSPITAL TWICE AND WAS PRESCRIBED ANTIBIOTICS FOR MASTITIS. CUSTOMER ALSO REPORTED THAT SHE DEVELOPED A BLISTER ON HER NIPPLE AND WAS PRESCRIBED A TOPICAL MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783519 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R