BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10156081 · Received June 15, 2020

    Report

    Report Number
    3012759464-2020-00003
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    February 20, 2020
    Report Date
    June 15, 2020
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    UDI-DI
    00858298006309
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A CUT ON THE NIPPLE WHICH WAS TREATED WITH UNKNOWN MEDICATION AND WAS HEALED AT 4 DAYS. THE WILLOW DEVICE WAS NOT RETURNED TO EXPLORAMED NC7 FOR EVALUATION, AS THE CUSTOMER CONTINUED PUMPING. 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 THE NIPPLE INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE ON 24-FEB-2020 THAT SHE EXPERIENCED A SMALL CUT ON HER RIGHT NIPPLE ON (B)(6) 2020 FROM USING WILLOW WHICH HEALED WITHIN 4 DAYS. CUSTOMER STATED THAT SHE EXPERIENCES NO PAIN WHILE PUMPING. CUSTOMER WENT TO DOCTOR AND WAS PRESCRIBED A CREAM. THE NAME OF THE CREAM WAS NOT PROVIDED, AND REPEATED ATTEMPTS TO CONTACT CUSTOMER FOR ADDITIONAL INFORMATION WERE NOT ANSWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618454 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDG30 00858298006309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention