BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WILLOW WEARABLE BREAST PUMP

    MDR report key: 13387038 · Received January 28, 2022

    Report

    Report Number
    3012759464-2022-00001
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    January 10, 2022
    Report Date
    January 28, 2022
    Manufacturer
    WILLOW INNOVATIONS, 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 · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED TO WILLOW CUSTOMER CARE THAT SHE HAD VISITED HER DOCTOR FOR MASTITIS (INITIATED (B)(6)) WHICH LED TO SEPSIS. THE DOCTOR RECOMMENDED SHE USE ANOTHER PUMP TO EMPTY HER BREASTS. THE CUSTOMER DID NOT RESPOND TO FOLLOW UP REGARDING MEDICATIONS PRESCRIBED OR TREATMENT GIVEN, BUT STATED THAT "THE MEDICATION HAS CUT HER MILK SUPPLY." CUSTOMER STATED THAT SHE WOULD CONTINUE USING THE PUMP UNTIL SHE RECEIVED ANOTHER PUMP FROM HER INSURANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640784 WILLOW WEARABLE BREAST PUMP POWERED BREAST PUMP HGX WILLOW INNOVATIONS, INC. PDW48 00858298006446

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other