BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10612060 · Received October 1, 2020

    Report

    Report Number
    1419937-2020-00108
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 9, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND RETURN OF HER ORIGINAL PUMP WAS REQUESTED FOR TESTING/EVALUATION. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA (B)(4), THE LEGAL MANUFACTURER IN (B)(4).

    Description of Event or Problem · 1

    ON 09/09/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE FLEX BREAST PUMP AND POWER CORD MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076240 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 162567 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1