BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLEX BREAST PUMP EN FR ES

    MDR report key: 10406625 · Received August 14, 2020

    Report

    Report Number
    1419937-2020-00083
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    July 21, 2020
    Manufacturer
    MEDELA AG
    Product Code
    HGX
    UDI-DI
    00020451379807
    PMA / PMN Number
    K191653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER SERVICE SENT THE CUSTOMER A REPLACEMENT DEVICE AND RETURN OF HER ORIGINAL DEVICE WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2020, THE CUSTOMER INDICATED SHE HAD BEEN USING THE MEDELA POWER SUPPLY AND CORD AND IT HAD BEEN PLUGGED INTO A WALL OUTLET WHEN THE ISSUE OCCURRED. THE DEVICE WAS RECEIVED ON (B)(6) 2020, BUT HAS NOT YET BEEN EVALUATED. 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 THE CHARGING PORT AND CHARGING CORD FOR HER FREESTYLE FLEX BREAST PUMP MELTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872771 FREESTYLE FLEX BREAST PUMP EN FR ES PUMP, BREAST, POWERED HGX MEDELA AG 101037980 161887 00020451379807

    Patients

    Seq Age Sex Outcome Treatment
    1 Other