BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10783379 · Received November 4, 2020

    Report

    Report Number
    3012759464-2020-00017
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 3, 2020
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    UDI-DI
    00858298006019
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED BLISTERS WHICH WERE TREATED BY TOPICAL ANTIBIOTICS. BLISTERS ON THE NIPPLE/ BREAST CAN BE CAUSED BY FREQUENT BREASTFEEDING WITH FRICTION [1] DUE TO IMPROPER LATCH, IMPROPER SIZING OF THE FLANGE, OR MALALIGNMENT WITHIN THE FLANGE. 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 WEARABLE BREAST PUMP CAUSED OR CONTRIBUTED TO THE INCIDENT OF BLISTER. 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 WILLOW CUSTOMER CARE ON (B)(6) 2020 THAT SHE WAS EXPERIENCING BLOOD BLISTERS. CUSTOMER SPOKE TO HER OB/GYN AND WAS PRESCRIBED A TOPICAL ANTIBIOTIC (GENTAMICIN SULFATE OINTMENT USP .1%) TO PREVENT INFECTION AND HELP THE SKIN HEAL FASTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250841 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDG01 00858298006019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention