BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10309435 · Received July 22, 2020

    Report

    Report Number
    1419937-2020-00071
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    May 4, 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. IN FOLLOW UP WITH A COMPLAINT HANDLER ON 07/03/2020 AND 07/04/2020, THE CUSTOMER INDICATED THAT THE PUMP WAS PLUGGED INTO A WALL OUTLET USING THE POWER SUPPLY THAT CAME WITH THE FREESTYLE FLEX PUMP WHEN THE MELTING ISSUE OCCURRED. SHE FURTHER INDICATED THAT SHE RETURNED THE PUMP AND POWER SUPPLY, THOUGH IT HAS NOT BEEN RECEIVED BY MEDELA AS OF THE DATE OF THIS REPORT. THIS ISSUE IS CURRENTLY UNDER INVESTIGATION BY MEDELA AG, THE LEGAL MANUFACTURER IN (B)(4). (B)(4).

    Description of Event or Problem · 1

    ON 05/04/2020, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE POWER CORD FOR HER FREESTYLE FLEX BREAST PUMP MELTED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775915 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 162084 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1