BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10423881 · Received August 19, 2020

    Report

    Report Number
    3012759464-2020-00010
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 19, 2020
    Report Date
    August 18, 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 A RASH WHICH WAS TREATED BY PRESCRIPTION STEROID CREAM AND ORAL MEDICATION. THE WILLOW DEVICE WAS NOT RETURNED TO EXPLORAMED NC7 FOR EVALUATION. ALL OF THE MATERIALS THAT COME INTO CONTACT WITH THE BREAST PASSED BIOCOMPATIBILITY EVALUATION PER ISO 10993-1:2009. ADDITIONALLY, 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 RASH.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON (B)(67 2020 THAT SHE EXPERIENCED A RASH ON BOTH BREASTS IN THE LOCATION OF THE INSERTS. SHE WAS PRESCRIBED TRIAMCINOLINE 0.1% CREAM, THEN ORAL PREDNISONE. CUSTOMER HAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891910 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention