BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 12235711 · Received July 27, 2021

    Report

    Report Number
    3012759464-2021-00002
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 26, 2021
    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 HOSPITALIZATION FOR MASTITIS, SEPSIS, AND PYELONEPHRITIS WHICH WAS TREATED BY INTRAVENOUS AND ORAL ANTIBIOTICS: VANCOMYCIN, MEROPENEM, CLINDAMYCIN, KEFLEX, AND VANTIN. THE ETIOLOGY OF THE SEPSIS IS UNCLEAR, BUT IS MORE LIKELY DUE TO THE PYELONEPHRITIS. THE WILLOW DEVICE HAS NOT YET BEEN RECEIVED BY EXPLORAMED NC7. 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 INCIDENCE OF INFECTION.

    Description of Event or Problem · 1

    ON 7/15/2021, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD BEEN SEEN BY A NURSE PRACTITIONER AND PRESCRIBED ORAL ANTIBIOTICS (DYNAPEN) ON (B)(6) 2021. SHE WAS SEEN BY AN OB/ GYN ON (B)(6) 2021 AND ADMITTED TO THE HOSPITAL. HER DIAGNOSIS WAS MASTITIS, SEPSIS, AND PYELONEPHRITIS. WHILE IN THE HOSPITAL, SHE WAS GIVEN IV ANTIBIOTICS (VANCOMYCIN, MEROPENEM, AND CLINDAMYCIN). UPON RELEASE, SHE WAS PRESCRIBED ORAL KEFLEX AND VANTIN. CUSTOMER WAS NOT ABLE TO BREASTFEED, HAND EXPRESS, OR PUMP. CUSTOMER HAS HEALED, BUT HAS THICKENED BREAST TISSUE WHICH REQUIRES FOLLOW-UP WITH A MAMMOGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129993 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX EXPLORAMED NC7, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R