BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST PUMP

    MDR report key: 9376555 · Received November 25, 2019

    Report

    Report Number
    MW5091289
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 19, 2019
    Report Date
    November 22, 2019
    Manufacturer
    WILLOW / EXPLORAMED NC7, INC.
    Product Code
    HGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WILLOW BREAST PUMPS OFFER "REPLACEMENT PUMPS" WHEN THEIR INITIAL PUMPS ARE DEFECTIVE. (B)(6), THESE REPLACEMENT PUMPS ARE SHIPPED IN BROWN BOXES WITHOUT MEDICAL SEALS. THEY ARE ALSO INFERIOR TO THE PURCHASED PUMPS SINCE THEY AREN'T LABELED BY SIDE (RIGHT OR LEFT). THEY APPEAR TO BE REFURBISHED PUMPS RATHER THAN NEW MEDICAL DEVICES. I WAS SHIPPED 2 REPLACEMENT PUMPS; ONE WITH A TORN PIECE OF PACKING TAPE HOLDING THE PLAIN BROWN BOX CLOSED, AND A SECOND WITH NO TAPE AT ALL. THIS IS AN UNSAFE MANNER FOR KEEPING, STORING AND SENDING MEDICAL DEVICES. THEIR CUSTOMER SERVICE DEPT REFUSED TO RECTIFY THE ISSUE AND JUST REQUESTED I SEND THE PUMP BACK WHEN I WOULDN'T USE IT SINCE I COULDN'T GUARANTEE IT WAS SAFE. THIS IS A BREACH OF THEIR WARRANTY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167074 BREAST PUMP PUMP, BREAST, POWERED HGX WILLOW / EXPLORAMED NC7, INC. 1.D
    1167075 BREAST PUMP PUMP, BREAST, POWERED HGX WILLOW / EXPLORAMED NC7, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR