BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    WILLOW GENERATION 3 BREAST PUMP

    MDR report key: 22075234 · Received May 22, 2025

    Report

    Report Number
    3012759464-2025-00001
    Event Type
    Injury
    Date Received
    May 22, 2025
    Date of Event
    August 1, 2024
    Report Date
    May 22, 2025
    Manufacturer
    WILLOW INNOVATIONS INC.
    Product Code
    HGX
    PMA / PMN Number
    K230570
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS UNDERWAY FOR THIS EVENT. FINAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A ROUTINE REVIEW OF COMPLAINT HANDLING PROCESS INCLUDING OUTSTANDING "OPEN" COMPLAINTS REVEALED THAT A NUMBER OF COMPLAINTS WERE MISCODED AS NON-ADVERSE EVENT CATEGORY. THIS PARTICULAR COMPLAINT (B)(4) WAS DISCOVERED AS PART OF THE REVIEW AND WAS SUBSEQUENTLY DETERMINED AS ADVERSE EVENT. THE COMPLAINT WAS THEN RECODED AS ARC "DIAGNOSED BREAST INFECTION/MASTITIS" ON (B)(6), 2025. DUE TO THE INITIAL MISCODING, THE DEVICE WAS DISPOSITIONED AS DISCARDED BY THE RETURN WAREHOUSE VENDOR AND THEREFORE NOT RETRIEVABLE FOR INVESTIGATION. A CORRECTIVE ACTION WAS INITIATED (CAPA-000016) TO EVALUATE THE STANDARD WAREHOUSE PRACTICE AND TO DETERMINE THE ROOT CAUSE INVESTIGATION. FURTHERMORE, THE DEVICE HISTORY RECORD (DHR) FOR WILLOW GEN3/360 PRODUCTION ORDER # (B)(4), WHICH INCLUDES THE SUBJECT DEVICE SERIAL # (B)(6), WAS REVIEWED AS PART OF THE INVESTIGATION UNDER THE COMPLAINT NO. (B)(4). THE DHR RECORD SHOWED THAT THE DEVICE MET ALL DEFINED MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE FROM THE MANUFACTURING SITE. THERE WERE NO NON-CONFORMANCES OR CORRECTIVE ACTION RECORDS CREATED AT THE TIME OF MANUFACTURE, INDICATING NO INHERENT ISSUES WITH THE UNIT PRIOR TO RELEASE FOR DISTRIBUTION. SEE APPENDIX 1 FOR A COPY OF THE DHR.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE DEVELOPED MASTITIS FROM USING THE WILLOW PUMP IN (B)(6) 2024. ON (B)(6) 2024 CUSTOMER REPORTED THAT THE MASTITIS LED TO THREE ABSCESSES IN HER RIGHT BREAST, TWO OF WHICH REQUIRED DRAINAGE. CUSTOMER WAS PRESCRIBED DICLOXACILLIN AND BACTRIM. THE CUSTOMER'S PHYSICIAN INSTRUCTED HER TO STOP BREASTFEEDING ON (B)(6) 2024 BECAUSE OF THE ABSCESSES. THIS COMPLAINT WAS CLASSIFIED AS "OTHER" ON (B)(6) 2024 AND UPON ROUTINE REVIEW, THE COMPLAINT WAS RECLASSIFIED TO "DIAGNOSED BREAST INFECTION/MASTITIS" ON (B)(6) 2025.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE DEVELOPED MASTITIS FROM USING THE WILLOW PUMP IN (B)(6) 2024. ON (B)(6) 2024 CUSTOMER REPORTED THAT THE MASTITIS LED TO THREE ABSCESSES IN HER RIGHT BREAST, TWO OF WHICH REQUIRED DRAINAGE. CUSTOMER WAS PRESCRIBED DICLOXACILLIN AND BACTRIM. THE CUSTOMER'S PHYSICIAN INSTRUCTED HER TO STOP BREASTFEEDING ON (B)(6) 2024 BECAUSE OF THE ABSCESSES. THIS COMPLAINT WAS CLASSIFIED AS "OTHER" ON 10-SEP-2024 AND UPON ROUTINE REVIEW, THE COMPLAINT WAS RECLASSIFIED TO "DIAGNOSED BREAST INFECTION/MASTITIS" ON 24-APR-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513949 WILLOW GENERATION 3 BREAST PUMP POWERED BREAST PUMP HGX WILLOW INNOVATIONS INC. TMN246514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention