BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BP ADV PERSONAL DOUBLE

    MDR report key: 6045519 · Received October 20, 2016

    Report

    Report Number
    1419937-2016-00272
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS SENT A REPLACEMENT PUMP AND HAS SINCE NOT REPORTED ANY ISSUES. 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. 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

    THE CUSTOMER REPORTED TO MEDELA CUSTOMER SERVICE ON (B)(6) 2016 THAT THE TRANSFORMER HOUSING FOR HER PUMP IN STYLE ADVANCED PERSONAL DOUBLE BREAST PUMP HAD FALLEN OFF, INDICATING A BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697293 BP ADV PERSONAL DOUBLE PUMP, BREAST, POWERED HGX MEDELA INC 57065/9207010 UNKNOWN/REV N

    Patients

    Seq Age Sex Outcome Treatment
    1