BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUM METRO BAG

    MDR report key: 3941922 · Received June 9, 2014

    Report

    Report Number
    1419937-2014-00477
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER ADAPTER WAS SENT TO THE CUSTOMER. 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 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. ATTEMPTS TO RETRIEVE THE PRODUCT AND TO GET ADDITIONAL COMPLAINT INFORMATION IS ONGOING. THE CAUSE OF THE BREACH IN THE REV N TRANSFORMER HAS NOT BEE DETERMINED AT THIS TIME. THE ISSUE IS CURRENTLY BEING INVESTIGATED UNDER (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED IN TO REPORT THAT THE POWER ADAPTER TO HER PUMP BROKE. WHEN SHE PULLED IT FROM THE OUTLET, THE ADAPTER CAME APART, WHICH IS A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334138 PUMP IN STYLE ADVANCED BREAST PUM METRO BAG HGX MEDELA, INC. 57036/9207010 REV N -3113

    Patients

    Seq Age Sex Outcome Treatment
    1