BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP IN STYLE ADVANCE BACK PACK

    MDR report key: 2050731 · Received March 31, 2011

    Report

    Report Number
    1419937-2011-00050
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    December 8, 2008
    Report Date
    December 8, 2008
    Manufacturer
    MEDELA, INC.
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A LABEL FOR THE RETURN OF THE PUMP WAS SENT TO THE CUSTOMER. THE ORIGINAL PUMP WAS RETURNED; HOWEVER, NO EVALUATION WAS DOCUMENTED, AND THE DEVICE HAS SINCE BEEN SCRAPPED. IT IS NOT DEFINITIVELY CLEAR WHETHER OR NOT THE PUMP CONTRIBUTED TO THE CUSTOMER'S ABSCESS. AS THERE IS NO INFORMATION TO REFUTE THE CUSTOMER'S CLAIM, A MEDWATCH IS BEING SUBMITTED. AS PART OF COMPLAINT REMEDIATION ACTIVITIES, HISTORICAL COMPLAINT RECORDS ARE BEING REVIEWED FOR POSSIBLE ADVERSE EVENTS. MEDELA IS COMMITTED TO CREATING AN EFFECTIVE COMPLAINT HANDLING PROCESS TO ASSURE COMPLAINTS ARE PROCESSED IN A TIMELY MANNER AND EVALUATED FOR PART 803 REPORTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SHE WAS USING THE BREAST PUMP AND DEVELOPED AN ABSCESS ON HER BREAST FROM THE PUMP. CUSTOMER STATED SHE'S NO LONGER ABLE TO BREASTFEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP IN STYLE ADVANCE BACK PACK HGX MEDELA, INC. 57062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other