BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 13831689 · Received March 20, 2022

    Report

    Report Number
    3012759464-2022-00003
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    January 30, 2022
    Report Date
    March 21, 2022
    Manufacturer
    WILLOW INNOVATIONS, INC.
    Product Code
    HGX
    UDI-DI
    00858298006293
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED DEVELOPMENT OF AN AREOLAR ABSCESS. CUSTOMER WAS TREATED WITH UNKNOWN MEDICATIONS. IT IS UNCLEAR IF THE ABSCESS OCCURRED BEFORE OR AFTER HER USE OF WILLOW WHICH WAS RECEIVED (B)(6) 2022. VISUAL INSPECTION ON THE PUMP FOUND FLUID INGRESS WITH FLUID RESIDUE ON THE FLEX CIRCUIT BOARD OF THE PUMP WHICH HAS THE POTENTIAL TO CAUSE FUNCTIONAL ISSUES. HOWEVER, VACUUM PROFILE TESTING OF THE RETURNED PUMP FOUND THE PUMP FUNCTIONING AS INTENDED. THE VACUUM PROFILE OF THE PUMP IS WITHIN SPECIFICATIONS, AND PUMPING SIMULATION WAS ALSO PERFORMED WITH NO ISSUES FOUND. 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 ABSCESS.

    Description of Event or Problem · 0

    ON (B)(6) 2022, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE DEVELOPED AN ABSCESS ON HER AREOLA (DATE OF OCCURRENCE IS AFTER (B)(6) 2022). IT IS UNCLEAR WHETHER OR NOT SHE WAS USING HER WILLOW PUMP DURING THE TIME THE ABSCESS DEVELOPED. AS OF (B)(6)2022, CUSTOMER'S ABSCESS HAD NOT FULLY HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517045 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX WILLOW INNOVATIONS, INC. PDW29 00858298006293

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R| H