BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10582944 · Received September 24, 2020

    Report

    Report Number
    1419937-2020-00105
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    September 3, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A NEW POWER ADAPTER AND RETURN OF THEIR ORIGINAL POWER ADAPTER WAS REQUESTED FOR TESTING/EVALUATION. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA AG, THE LEGAL MANUFACTURER IN (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE FLEX BREAST PUMP WAS PLUGGED IN TO BE CHARGED AND THE ADAPTER MELTED INTO THE PUMP. THE PUMP WILL NO LONGER POWER ON. SHE WAS USING THE POWER SUPPLY THAT CAME WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043178 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 160190 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1