BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10440548 · Received August 23, 2020

    Report

    Report Number
    3012759464-2020-00012
    Event Type
    Injury
    Date Received
    August 23, 2020
    Date of Event
    July 20, 2020
    Report Date
    August 22, 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 SEPSIS, SECONDARY TO MASTITIS, TREATED BY INTRAVENOUS AND ORAL ANTIBIOTICS. THE CUSTOMER MAY HAVE BEEN USING AN INCORRECT FLANGE SIZE, AS SHE NOTED USING A 30.5 FLANGE WITH ANOTHER PUMP (OUTSIDE OF WILLOW'S RANGE OF FLANGE SIZES). THE CUSTOMER NOTED PUMPING DURING TREATMENT USING AN ALTERNATE PUMP. THE INITIATING FACTOR IN THIS SITUATION, MASTITIS, IS PRIMARILY CAUSED BY 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%. THE DEVICE HAS NOT 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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 24-JUL-2020 THAT SHE HOSPITALIZED ON (B)(6) 2020 FOR SEPSIS SECONDARY TO MASTITIS. WHILE IN THE HOSPITAL, SHE WAS TREATED WITH WAS ON INTRAVENOUS VANCOMYCIN AND WAS GIVEN CLINDAMYCIN AT DISCHARGE ON (B)(6) 2020. CUSTOMER WAS HOSPITALIZED A SECOND TIME ON (B)(6) 2020 FOR (B)(6). SHE WAS DISCHARGED AFTER 3 DAYS WITH CONTINUED TREATMENT OF VANCOMYCIN VIA A PICC LINE. CUSTOMER NOTED PUMPING DURING TREATMENT USING AN ALTERNATE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904908 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R