BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

    MDR report key: 4062642 · Received August 25, 2014

    Report

    Report Number
    1419937-2014-00623
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THE TIME OF THIS REPORT. THEREFORE NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED, RESULTING IN NEW, CHANGED OR CORRECTED INFORMATION 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 CUSTOMER SERVICE TO REPORT THAT THE HOUSING ON HER TRANSFORMER (SHELL PART) CAME APART AND IS DETACHED FROM THE CORD. MOM SAID THE OUTER PART OF THE TRANSFORMER CAME OFF AND THERE ARE EXPOSED WIRES, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515389 PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE HGX MEDELA, INC. 57063/920710 REV N -3113

    Patients

    Seq Age Sex Outcome Treatment
    1