BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10857099 · Received November 17, 2020

    Report

    Report Number
    3012759464-2020-00016
    Event Type
    Injury
    Date Received
    November 17, 2020
    Date of Event
    June 22, 2020
    Report Date
    October 2, 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 THRUSH WHICH WAS TREATED BY A DOCTOR PRESCRIBED TOPICAL ANTIBIOTIC MEDICATION. THRUSH IS CAUSED BY A YEAST FUNGUS. YEAST GROWS IN MOIST, WARM ENVIRONMENTS. RISK OF DEVELOPING THRUSH CAN BE INCREASED BY RECENT COURSE OF ANTIBIOTICS1, CRACKED OR DAMAGED NIPPLES1, ORAL CONTRACEPTIVES OR STEROIDS CLOTHING NOT DESIGNED FOR BREASTFEEDING THAT TRAPS MOISTURE2, AND HOT, HUMID CONDITIONS. THE WILLOW DEVICE WAS NOT 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 BREAST PUMP CAUSED OR CONTRIBUTED TO THIS INCIDENT OF THRUSH. LA LECHE LEAGUE INTERNATIONAL, HTTPS://WWW.LLLI.ORG/BREASTFEEDING-INFO/THRUSH/ HEALTHLINE, NIPPLE THRUSH AND BREASTFEEDING, HTTPS://WWW.HEALTHLINE.COM/HEALTH/NIPPLE-THRUSH#TAKEAWAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 02 OCT 2020 THAT SHE HAD BEEN DIAGNOSED WITH THRUSH BY HER DOCTOR AND RECEIVED A PRESCRIPTION COMPOUNDED NIPPLE OINTMENT CONTAINING BETAMETHASONE, MICONAZOLE, MUPIROCIN, AND IN ADDITION, GENTIAN VIOLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320725 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention