BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 3964712 · Received June 2, 2014

    Report

    Report Number
    1419937-2014-00443
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT ADAPTER WAS SENT TO THE CUSTOMER. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A FOLLOW-UP REPORT WILL BE FILED AT THAT TIME. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED INTO REPORT THAT HER TRANSFORMER HOUSING HAS A WIDE CRACK IN IT STARTING AT THE BACK GOING ALL THE WAY UP AND WIRES ARE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322532 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/9207010 REV N - 1613

    Patients

    Seq Age Sex Outcome Treatment
    1