BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10322156 · Received July 24, 2020

    Report

    Report Number
    1419937-2020-00074
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    June 30, 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

    CUSTOMER SERVICE REQUESTED RETURN OF HER ORIGINAL PUMP FOR TESTING/EVALUATION AND PROOF OF PURCHASE FOR A REPLACEMENT PUMP. AS OF THE DATE OF THIS REPORT, THE CUSTOMER HAS NOT SENT IN HER PROOF OF PURCHASE. THE CUSTOMER WAS CONTACTED BY A COMPLAINT HANDLER ON MULTIPLE OCCASIONS, INCLUDING IN WRITING AND BY PHONE, TO GET ADDITIONAL INFORMATION AND TO OFFER A REPLACEMENT PUMP, WITH NO RESPONSE AS OF THE DATE OF THIS REPORT. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA AG, THE LEGAL MANUFACTURER IN (B)(4).

    Description of Event or Problem · 1

    ON 06/30/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE CHARGING PORT ON HER FREESTYLE FLEX BREAST PUMP HAD MELTED AND THE PUMP WAS NO LONGER TURNING ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783138 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 160120 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1