BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 13831801 · Received March 20, 2022

    Report

    Report Number
    3012759464-2022-00002
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    September 14, 2021
    Report Date
    February 18, 2022
    Manufacturer
    WILLOW INNOVATIONS, INC.
    Product Code
    HGX
    UDI-DI
    00858298006187
    PMA / PMN Number
    K191577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED INJURY TO HER NIPPLE TISSUE AND INFECTION WHICH WAS TREATED BY DOCTOR VISIT AND ORAL ANTIBIOTICS. THE CUSTOMER REPORTED THAT SHE WAS NOT ABLE TO BREASTFEED ON THE INJURED BREAST. THE DEVICE HAS NOT BEEN RETURNED TO WILLOW INNOVATIONS, INC. FOR EVALUATION. 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 INJURY TO NIPPLE TISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT ON (B)(6) 2021 SHE HAD EXPERIENCED INJURY TO HER NIPPLE TISSUE. HER OB/GYN PRESCRIBED ORAL ANTIBIOTICS DUE TO INFECTION (2 ROUNDS). CUSTOMER STATED THAT SHE WOULD NO LONGER BE ABLE TO BF, AND MAY NEED TO HAVE CORRECTIVE SURGERY. CUSTOMER STATED THAT HER INITIAL INJURY HEALED, ALTHOUGH NOT PROPERLY. AFTER THE INJURY, SHE STATED THAT SHE WAS STILL PUMPING, USING ONE PUMP. NO FURTHER FOLLOW UP WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545617 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX WILLOW INNOVATIONS, INC. PRW31 00858298006187

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other