BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10862424 · Received November 18, 2020

    Report

    Report Number
    1419937-2020-00130
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    September 22, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED MEDELA LLC TWO MORE TIMES ON (B)(6) 2020, ALLEGING HER PUMP DISPLAY IS FROZEN AND CHARGING DID NOT HELP AND THE PUMP WOULD STILL RANDOMLY SHUT OFF AND WON'T TURN BACK ON. SHE EXCLUSIVELY PUMPS AND THIS IS A PROBLEM BECAUSE SHE CAN'T FINISH HER PUMPING SESSIONS, THIS HAS LED TO HER HAVING CLOGGED DUCTS. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2020, THE CUSTOMER INDICATED THAT SHE DEVELOPED CLOGGED DUCTS THREE TIMES BEGINNING (B)(6) 2020. SHE WAS PRESCRIBED TWO DIFFERENT MEDICATIONS, THE FIRST MEDICATION DID NOT WORK. SHE STATED HER CLOGGED DUCTS ARE RESOLVED AND HER REPLACEMENT PUMP WAS WORKING WITHOUT ISSUE. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT HER FREESTYLE FLEX BREAST PUMP WOULD NOT POWER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323692 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 166737 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other