BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 12222174 · Received July 23, 2021

    Report

    Report Number
    3012759464-2021-00001
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    June 19, 2021
    Report Date
    July 23, 2021
    Manufacturer
    EXPLORAMED NC7, INC.
    Product Code
    HGX
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A TEAR ON THE NIPPLE WHICH WAS TREATED WITH SURGERY AND PRESCRIBED HYDROCODONE/ ACETAMINOPHEN. THE CUSTOMER HAS NOT COMPLETELY HEALED. THE DEVICE HAS NOT BEEN RETURNED TO EXPLORAMED NC7 FOR EVALUATION. 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 (B)(6) 2021 THAT SHE EXPERIENCED A TEAR ON HER NIPPLE. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS TREATED WITH SURGERY TO REPAIR THE TEAR. SHE RECEIVED HYDROCODONE/ACETOMINOPHEN BY DOCTOR'S PRESCRIPTION. THE CUSTOMER REPORTED THAT SHE IS UNABLE TO PUMP OR BREASTFEED FROM THIS BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118800 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R