BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADV PERSONAL DOUBLE

    MDR report key: 6132815 · Received November 29, 2016

    Report

    Report Number
    1419937-2016-00307
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 19, 2016
    Report Date
    November 29, 2016
    Manufacturer
    MEDELA, INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT TRANSFORMER WAS SENT TO THE CUSTOMER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION/INVESTIGATION AT THIS TIME. THEREFORE, NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEEN DETERMINED AT THIS TIME. IT IS CURRENTLY BEING INVESTIGATED UNDER IR (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE ON (B)(6) 2016, THAT THE POWER CORD ON HER PUMP IN STYLE ADVANCED IS BROKEN AND PRONGS DON'T STAY IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784127 BP ADV PERSONAL DOUBLE PUMP, BREAST, POWERED HGX MEDELA, INC 57065/9207010 REV N- 1613

    Patients

    Seq Age Sex Outcome Treatment
    1