BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 10429229 · Received August 19, 2020

    Report

    Report Number
    3012759464-2020-00011
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 19, 2020
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    UDI-DI
    00858298006484
    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 A PRESCRIBED TOPICAL CREAM. THE FLANGE SIZE MAY NOT HAVE BEEN APPROPRIATE, AS CUSTOMER HAD NOT SIZED PER THE INSTRUCTIONS FOR USE. CUSTOMER CONTINUED TO PUMP AND BREASTFEED THROUGHOUT. THE DEVICE HAS NOT YET BEEN RETURNED TO EXPLORAMED NC7 FOR EVALUATION. 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 20 JUL 2020 THAT SHE EXPERIENCED A CUT ON HER NIPPLE. SHE WAS PRESCRIBED A TOPICAL CREAM. CUSTOMER CONTINUES TO PUMP AND BREASTFEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888813 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW50 00858298006484

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention